acetaminophen diphenhydramine hcl

Generic: acetaminophen diphenhydramine hcl

Labeler: freds, inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH NOT FINAL Inactive Finished

Drug Facts

Product Profile

Brand Name acetaminophen diphenhydramine hcl
Generic Name acetaminophen diphenhydramine hcl
Labeler freds, inc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

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

Manufacturer
FREDS, INC

Identifiers & Regulatory

Product NDC 55315-988
Product ID 55315-988_5486d426-470a-0bed-e054-00144ff8d46c
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH NOT FINAL
Application Number part343
Listing Expiration 2026-12-31
Marketing Start 2017-08-17

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 55315988
Hyphenated Format 55315-988

Supplemental Identifiers

RxCUI
1117245
UPC
0084579131624
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 part343 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
  • 25 mg/1
source: ndc
Packaging
  • 24 CAPSULE in 1 BOTTLE (55315-988-24)
source: ndc

Packages (1)

55315-988-24 24 CAPSULE in 1 BOTTLE (55315-988-24)

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": "5486d426-470a-0bed-e054-00144ff8d46c", "openfda": {"upc": ["0084579131624"], "unii": ["362O9ITL9D", "TC2D6JAD40"], "rxcui": ["1117245"], "spl_set_id": ["5486d426-4709-0bed-e054-00144ff8d46c"], "manufacturer_name": ["FREDS, INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 CAPSULE in 1 BOTTLE (55315-988-24)", "package_ndc": "55315-988-24", "marketing_start_date": "20170817"}], "brand_name": "Acetaminophen Diphenhydramine HCl", "product_id": "55315-988_5486d426-470a-0bed-e054-00144ff8d46c", "dosage_form": "CAPSULE", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "55315-988", "generic_name": "Acetaminophen Diphenhydramine HCl", "labeler_name": "FREDS, 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": "part343", "marketing_category": "OTC MONOGRAPH NOT FINAL", "marketing_start_date": "20170817", "listing_expiration_date": "20261231"}