acetaminophen and diphenhydramine hydrochloride

Generic: acetaminophen and diphenhydramine hydrochloride

Labeler: bi-mart
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name acetaminophen and diphenhydramine hydrochloride
Generic Name acetaminophen and diphenhydramine hydrochloride
Labeler bi-mart
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acetaminophen 500 mg/1, diphenhydramine 25 mg/1

Manufacturer
Bi-Mart

Identifiers & Regulatory

Product NDC 37835-537
Product ID 37835-537_38f722c5-1d77-e710-e063-6394a90ac4d2
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2026-12-31
Marketing Start 2025-02-01

Pharmacologic Class

Established (EPC)
histamine-1 receptor antagonist [epc]
Mechanism of Action
histamine h1 receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 37835537
Hyphenated Format 37835-537

Supplemental Identifiers

RxCUI
1092189
UPC
0071357006748 0071357008216
UNII
362O9ITL9D 8GTS82S83M
NUI
N0000000190 N0000175587

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

Resolved Composition

Strengths
  • 500 mg/1
  • 25 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (37835-537-01)
  • 250 TABLET in 1 BOTTLE (37835-537-25)
source: ndc

Packages (2)

37835-537-01 100 TABLET in 1 BOTTLE (37835-537-01) 37835-537-25 250 TABLET in 1 BOTTLE (37835-537-25)

Ingredients (2)

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

Linked Drug Pages (1)

Acetaminophen and Diphenhydramine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "38f722c5-1d77-e710-e063-6394a90ac4d2", "openfda": {"nui": ["N0000000190", "N0000175587"], "upc": ["0071357006748", "0071357008216"], "unii": ["362O9ITL9D", "8GTS82S83M"], "rxcui": ["1092189"], "spl_set_id": ["70084eea-1480-4c46-b849-4c779319cb74"], "pharm_class_epc": ["Histamine-1 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H1 Receptor Antagonists [MoA]"], "manufacturer_name": ["Bi-Mart"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (37835-537-01)", "package_ndc": "37835-537-01", "marketing_start_date": "20250201"}, {"sample": false, "description": "250 TABLET in 1 BOTTLE (37835-537-25)", "package_ndc": "37835-537-25", "marketing_start_date": "20250201"}], "brand_name": "Acetaminophen and Diphenhydramine Hydrochloride", "product_id": "37835-537_38f722c5-1d77-e710-e063-6394a90ac4d2", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "37835-537", "generic_name": "Acetaminophen and Diphenhydramine Hydrochloride", "labeler_name": "Bi-Mart", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Acetaminophen and Diphenhydramine Hydrochloride", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "500 mg/1"}, {"name": "DIPHENHYDRAMINE", "strength": "25 mg/1"}], "application_number": "M013", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250201", "listing_expiration_date": "20261231"}