maximum strength pepcid ac icy cool mint

Generic: famotidine

Labeler: kenvue brands llc
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name maximum strength pepcid ac icy cool mint
Generic Name famotidine
Labeler kenvue brands llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

famotidine 20 mg/1

Manufacturer
Kenvue Brands LLC

Identifiers & Regulatory

Product NDC 16837-889
Product ID 16837-889_21af4ff4-5892-565e-e063-6394a90aa728
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA020325
Listing Expiration 2026-12-31
Marketing Start 2024-03-11

Pharmacologic Class

Established (EPC)
histamine-2 receptor antagonist [epc]
Mechanism of Action
histamine h2 receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16837889
Hyphenated Format 16837-889

Supplemental Identifiers

RxCUI
104094 310273
UPC
0716837879404
UNII
5QZO15J2Z8
NUI
N0000000151 N0000175784

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name maximum strength pepcid ac icy cool mint (source: ndc)
Generic Name famotidine (source: ndc)
Application Number NDA020325 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (16837-889-20) / 20 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (16837-889-40) / 40 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (2)

16837-889-20 1 BOTTLE in 1 CARTON (16837-889-20) / 20 TABLET, FILM COATED in 1 BOTTLE 16837-889-40 1 BOTTLE in 1 CARTON (16837-889-40) / 40 TABLET, FILM COATED in 1 BOTTLE

Ingredients (1)

famotidine (20 mg/1)

Linked Drug Pages (1)

Maximum Strength PEPCID AC Icy Cool Mint ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "21af4ff4-5892-565e-e063-6394a90aa728", "openfda": {"nui": ["N0000000151", "N0000175784"], "upc": ["0716837879404"], "unii": ["5QZO15J2Z8"], "rxcui": ["104094", "310273"], "spl_set_id": ["0f343092-4fc7-1fff-e063-6294a90aba6e"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (16837-889-20)  / 20 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "16837-889-20", "marketing_start_date": "20240311"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (16837-889-40)  / 40 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "16837-889-40", "marketing_start_date": "20240311"}], "brand_name": "Maximum Strength PEPCID AC Icy Cool Mint", "product_id": "16837-889_21af4ff4-5892-565e-e063-6394a90aa728", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "16837-889", "generic_name": "Famotidine", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Maximum Strength PEPCID AC", "brand_name_suffix": "Icy Cool Mint", "active_ingredients": [{"name": "FAMOTIDINE", "strength": "20 mg/1"}], "application_number": "NDA020325", "marketing_category": "NDA", "marketing_start_date": "20240311", "listing_expiration_date": "20261231"}