63187-122 NDC - MEDI-SULTING TOPICAL PAIN RELIEF ()

Drug Information

  • Product NDC: 63187-122
  • Proprietary Name: MEDI-SULTING TOPICAL PAIN RELIEF
  • Non Proprietary Name:
  • Active Ingredient(s): 100 mg/1 ORPHENADRINE CITRATE
  • Administration Route(s):
  • Dosage Form(s):
  • Pharmacy Class(es): Centrally-mediated Muscle Relaxation [PE]; Muscle Relaxant [EPC]

Labeler Information

Field Name Field Value
Labeler Name: Proficient Rx LP
Product Type:
FDA Application Number: part348
Marketing Category: OTC MONOGRAPH NOT FINAL
Start Marketing Date:8/18/2012
End Marketing Date:1/2/2015

Package Information

No. Package Code Package Description Billing Unit
163187-122-02120 mL in 1 TUBE (63187-122-02)
263187-122-2020 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-122-20)
363187-122-3030 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-122-30)EA
463187-122-6060 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-122-60)EA
563187-122-9090 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-122-90)

NDC Record

Field Name Field Value Definition
PRODUCT NDC63187-122The 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.
PROPRIETARY NAMEMEDI-SULTING TOPICAL PAIN RELIEFThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE8/18/2012This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEOTC MONOGRAPH NOT FINALProduct 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 NUMBERpart348This 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 NAMEProficient Rx LPName of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC63187-122The 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.
PROPRIETARY NAMEOrphenadrine CitrateThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE6/19/1998This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEANDAProduct 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 NUMBERANDA040284This 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 NAMEProficient Rx LPName of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 4/4/2025

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