0135-0623 NDC - TUMS CHEWY BITES ()

Drug Information

  • Product NDC: 0135-0623
  • Proprietary Name: Tums Chewy Bites
  • Non Proprietary Name:
  • Active Ingredient(s): 750 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 Holdings (US) LLC
Product Type:
FDA Application Number: part331
Marketing Category: OTC MONOGRAPH FINAL
Start Marketing Date:10/1/2017
End Marketing Date:12/17/2019

Package Information

No. Package Code Package Description Billing Unit
10135-0623-0160 TABLET, CHEWABLE in 1 BOTTLE (0135-0623-01)
20135-0623-0160 TABLET, CHEWABLE in 1 BOTTLE (0135-0623-01)

NDC Record

Field Name Field Value Definition
PRODUCT NDC0135-0623The 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 DATE10/1/2017This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEOTC MONOGRAPH 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 NUMBERpart331This 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 Holdings (US) LLCName of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC0135-0623The 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 NAMETumsThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE8/1/2017This 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: 5/26/2025

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