acetaminophen diphenhydramine hcl

Generic: acetaminophen diphenhydramine hcl

Labeler: granules usa, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name acetaminophen diphenhydramine hcl
Generic Name acetaminophen diphenhydramine hcl
Labeler granules usa, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acetaminophen 500 mg/1, diphenhydramine hydrochloride 25 mg/1

Manufacturer
Granules USA, Inc.

Identifiers & Regulatory

Product NDC 69848-014
Product ID 69848-014_4690f59f-4424-6231-e063-6294a90a8ca7
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2026-12-31
Marketing Start 2019-07-01

Pharmacologic Class

Classes
histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69848014
Hyphenated Format 69848-014

Supplemental Identifiers

RxCUI
1092189
UNII
362O9ITL9D TC2D6JAD40

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 acetaminophen diphenhydramine hcl (source: ndc)
Generic Name acetaminophen diphenhydramine hcl (source: ndc)
Application Number M013 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
  • 25 mg/1
source: ndc
Packaging
  • 20 TABLET in 1 BOTTLE (69848-014-02)
  • 50 TABLET in 1 BOTTLE (69848-014-05)
  • 150 TABLET in 1 BOTTLE (69848-014-15)
source: ndc

Packages (3)

69848-014-02 20 TABLET in 1 BOTTLE (69848-014-02) 69848-014-05 50 TABLET in 1 BOTTLE (69848-014-05) 69848-014-15 150 TABLET in 1 BOTTLE (69848-014-15)

Ingredients (2)

acetaminophen (500 mg/1) diphenhydramine hydrochloride (25 mg/1)

Linked Drug Pages (1)

Acetaminophen Diphenhydramine HCl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4690f59f-4424-6231-e063-6294a90a8ca7", "openfda": {"unii": ["362O9ITL9D", "TC2D6JAD40"], "rxcui": ["1092189"], "spl_set_id": ["8c9f68e3-fedc-6457-e053-2995a90a045a"], "manufacturer_name": ["Granules USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET in 1 BOTTLE (69848-014-02)", "package_ndc": "69848-014-02", "marketing_start_date": "20190701"}, {"sample": false, "description": "50 TABLET in 1 BOTTLE (69848-014-05)", "package_ndc": "69848-014-05", "marketing_start_date": "20190701"}, {"sample": false, "description": "150 TABLET in 1 BOTTLE (69848-014-15)", "package_ndc": "69848-014-15", "marketing_start_date": "20190701"}], "brand_name": "Acetaminophen Diphenhydramine HCl", "product_id": "69848-014_4690f59f-4424-6231-e063-6294a90a8ca7", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "69848-014", "generic_name": "Acetaminophen Diphenhydramine HCl", "labeler_name": "Granules USA, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Acetaminophen Diphenhydramine HCl", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "500 mg/1"}, {"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "M013", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20190701", "listing_expiration_date": "20261231"}