84509-005 NDC - MASSAGE CREAM FOR STRETCH MARKS (HELIANTHUS ANNUUS (SUNFLOWER) SEED 0IL,BUTYROSPERMUM PARKII (SHEA) BUTER,ARGANIA SPINOSA KERNEL 0IL,TOCOPHEROL,CENTELLA ASIATICA EXTRACT,CERAMIDE NP,SOLUBLE COLLAGEN,HYDROLYZED ELASTIN,PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL)

Drug Information

  • Product NDC: 84509-005
  • Proprietary Name: Massage cream for stretch marks
  • Non Proprietary Name: Helianthus Annuus (Sunflower) Seed 0il,Butyrospermum Parkii (Shea) Buter,Argania Spinosa Kernel 0il,Tocopherol,Centella Asiatica Extract,Ceramide NP,Soluble Collagen,Hydrolyzed Elastin,Prunus Amygdalus Dulcis (Sweet Almond) Oil
  • Active Ingredient(s): 2000; 2000; 2000; 100; 100; 100; 4000; 5000; 2000 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL ALMOND OIL; ARGAN OIL; CENTELLA ASIATICA TRITERPENOIDS; CERAMIDE NP; COLLAGEN, SOLUBLE, FISH SKIN; HYDROLYZED BOVINE ELASTIN (BASE; 1000 MW); SHEA BUTTER; SUNFLOWER OIL; TOCOPHEROL
  • Administration Route(s): TOPICAL
  • Dosage Form(s): CREAM

Labeler Information

Field Name Field Value
Labeler Name: Guangzhou Senmai Biotechnology Co.
Product Type: HUMAN OTC DRUG
FDA Application Number: M016
Marketing Category: OTC MONOGRAPH DRUG
Start Marketing Date:7/22/2024

Package Information

No. Package Code Package Description Billing Unit
184509-005-01100 mL in 1 BOTTLE (84509-005-01)

NDC Record

Field Name Field Value Definition
PRODUCT NDC84509-005The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN OTC DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEMassage cream for stretch marksThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEHelianthus Annuus (Sunflower) Seed 0il,Butyrospermum Parkii (Shea) Buter,Argania Spinosa Kernel 0il,Tocopherol,Centella Asiatica Extract,Ceramide NP,Soluble Collagen,Hydrolyzed Elastin,Prunus Amygdalus Dulcis (Sweet Almond) OilThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMECREAMThe translation of the dosage form Code submitted by the firm.
ROUTE NAMETOPICALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE7/22/2024This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEOTC MONOGRAPH DRUGProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERM016This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEGuangzhou Senmai Biotechnology Co.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEALMOND OIL; ARGAN OIL; CENTELLA ASIATICA TRITERPENOIDS; CERAMIDE NP; COLLAGEN, SOLUBLE, FISH SKIN; HYDROLYZED BOVINE ELASTIN (BASE; 1000 MW); SHEA BUTTER; SUNFLOWER OIL; TOCOPHEROLAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH2000; 2000; 2000; 100; 100; 100; 4000; 5000; 2000 
ACTIVE INGRED UNITmg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL 

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This page was last updated on: 7/25/2025

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