diphenhydramine

Generic: diphenhydramine hydrochloride

Labeler: aaa pharmaceutical, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name diphenhydramine
Generic Name diphenhydramine hydrochloride
Labeler aaa pharmaceutical, inc.
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 25 mg/1

Manufacturer
AAA Pharmaceutical, Inc.

Identifiers & Regulatory

Product NDC 57344-090
Product ID 57344-090_284d200c-7ba4-d545-e063-6394a90a4d51
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2012-04-13

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 57344090
Hyphenated Format 57344-090

Supplemental Identifiers

RxCUI
1049630
UPC
0099581910914
UNII
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 diphenhydramine (source: ndc)
Generic Name diphenhydramine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 4 BLISTER PACK in 1 CARTON (57344-090-02) / 12 TABLET, COATED in 1 BLISTER PACK
  • 1 BOTTLE, PLASTIC in 1 CARTON (57344-090-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC
source: ndc

Packages (2)

57344-090-02 4 BLISTER PACK in 1 CARTON (57344-090-02) / 12 TABLET, COATED in 1 BLISTER PACK 57344-090-03 1 BOTTLE, PLASTIC in 1 CARTON (57344-090-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC

Ingredients (1)

diphenhydramine hydrochloride (25 mg/1)

Linked Drug Pages (1)

Diphenhydramine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "284d200c-7ba4-d545-e063-6394a90a4d51", "openfda": {"upc": ["0099581910914"], "unii": ["TC2D6JAD40"], "rxcui": ["1049630"], "spl_set_id": ["76724432-ff3c-404f-ba1f-5af68e3ab8c4"], "manufacturer_name": ["AAA Pharmaceutical, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 BLISTER PACK in 1 CARTON (57344-090-02)  / 12 TABLET, COATED in 1 BLISTER PACK", "package_ndc": "57344-090-02", "marketing_start_date": "20120413"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (57344-090-03)  / 100 TABLET, COATED in 1 BOTTLE, PLASTIC", "package_ndc": "57344-090-03", "marketing_start_date": "20171127"}], "brand_name": "Diphenhydramine", "product_id": "57344-090_284d200c-7ba4-d545-e063-6394a90a4d51", "dosage_form": "TABLET, COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "57344-090", "generic_name": "DIPHENHYDRAMINE HYDROCHLORIDE", "labeler_name": "AAA Pharmaceutical, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Diphenhydramine", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20120413", "listing_expiration_date": "20261231"}