0135-0138 NDC - PANADOL ()

Drug Information

  • Product NDC: 0135-0138
  • Proprietary Name: PANADOL
  • Non Proprietary Name:
  • Active Ingredient(s): 1000 mg/1 CALCIUM CARBONATE
  • Administration Route(s):
  • Dosage Form(s):
  • Pharmacy Class(es): Blood Coagulation Factor [EPC]; Calcium [CS]; Cations; Divalent [CS]; Increased Coagulation Factor Activity [PE]; Phosphate Binder [EPC]; Phosphate Chelating Activity [MoA]

Labeler Information

Field Name Field Value
Labeler Name: GlaxoSmithKline Consumer Healthcare LP
Product Type:
FDA Application Number: part343
Marketing Category: OTC MONOGRAPH NOT FINAL
Start Marketing Date:1/3/2011
End Marketing Date:12/2/2014

Package Information

No. Package Code Package Description Billing Unit
10135-0138-011 BOTTLE in 1 CARTON (0135-0138-01) / 60 mL in 1 BOTTLE
20135-0138-021 BOTTLE in 1 CARTON (0135-0138-02) / 120 mL in 1 BOTTLE
30135-0138-03200 TABLET, CHEWABLE in 1 BOTTLE (0135-0138-03)
40135-0138-0315 mL in 1 BOTTLE (0135-0138-03)

NDC Record

Field Name Field Value Definition
PRODUCT NDC0135-0138The 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 NAMEPANADOLThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE1/3/2011This 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 NUMBERpart343This 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 NAMEGlaxoSmithKline Consumer Healthcare LPName of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC0135-0138The 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 NAMETums Chewy BitesThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE6/26/2022This 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 NUMBERM001This 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 NAMEHaleon US Holdings LLCName 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