sleep aid

Generic: diphenhydramine hcl

Labeler: fsa store inc. (caring mills)
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name sleep aid
Generic Name diphenhydramine hcl
Labeler fsa store inc. (caring mills)
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 50 mg/1

Manufacturer
FSA Store Inc. (Caring Mills)

Identifiers & Regulatory

Product NDC 81522-916
Product ID 81522-916_28bc4fe9-aac8-4354-a3ab-c55e6fede243
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M010
Listing Expiration 2026-12-31
Marketing Start 2021-10-08

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 81522916
Hyphenated Format 81522-916

Supplemental Identifiers

RxCUI
1020477
UPC
0359726916332
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 sleep aid (source: ndc)
Generic Name diphenhydramine hcl (source: ndc)
Application Number M010 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 BOX (81522-916-32) / 32 CAPSULE in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

81522-916-32 1 BOTTLE, PLASTIC in 1 BOX (81522-916-32) / 32 CAPSULE in 1 BOTTLE, PLASTIC

Ingredients (1)

diphenhydramine hydrochloride (50 mg/1)

Linked Drug Pages (1)

Sleep Aid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "28bc4fe9-aac8-4354-a3ab-c55e6fede243", "openfda": {"upc": ["0359726916332"], "unii": ["TC2D6JAD40"], "rxcui": ["1020477"], "spl_set_id": ["9d32a3a1-9528-4de4-9fd1-1d01a1ad93e9"], "manufacturer_name": ["FSA Store Inc. (Caring Mills)"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 BOX (81522-916-32)  / 32 CAPSULE in 1 BOTTLE, PLASTIC", "package_ndc": "81522-916-32", "marketing_start_date": "20211008"}], "brand_name": "Sleep Aid", "product_id": "81522-916_28bc4fe9-aac8-4354-a3ab-c55e6fede243", "dosage_form": "CAPSULE", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "81522-916", "generic_name": "Diphenhydramine HCL", "labeler_name": "FSA Store Inc. (Caring Mills)", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Sleep Aid", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "M010", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20211008", "listing_expiration_date": "20261231"}