topcare childrens allergy

Generic: diphenhydramine hydrochloride

Labeler: topco associates llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name topcare childrens allergy
Generic Name diphenhydramine hydrochloride
Labeler topco associates llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 12.5 mg/5mL

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 36800-379
Product ID 36800-379_8febc051-c865-4f72-8389-84bdb89f1ee6
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 1987-12-15

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 36800379
Hyphenated Format 36800-379

Supplemental Identifiers

RxCUI
1049906
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 topcare childrens allergy (source: ndc)
Generic Name diphenhydramine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (36800-379-26) / 118 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (36800-379-34) / 237 mL in 1 BOTTLE
source: ndc

Packages (2)

36800-379-26 1 BOTTLE in 1 CARTON (36800-379-26) / 118 mL in 1 BOTTLE 36800-379-34 1 BOTTLE in 1 CARTON (36800-379-34) / 237 mL in 1 BOTTLE

Ingredients (1)

diphenhydramine hydrochloride (12.5 mg/5mL)

Linked Drug Pages (1)

Topcare childrens allergy ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8febc051-c865-4f72-8389-84bdb89f1ee6", "openfda": {"unii": ["TC2D6JAD40"], "rxcui": ["1049906"], "spl_set_id": ["6b784cde-3152-4421-a825-dd1fc601aa7a"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (36800-379-26)  / 118 mL in 1 BOTTLE", "package_ndc": "36800-379-26", "marketing_start_date": "19871215"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (36800-379-34)  / 237 mL in 1 BOTTLE", "package_ndc": "36800-379-34", "marketing_start_date": "20031118"}], "brand_name": "Topcare childrens allergy", "product_id": "36800-379_8febc051-c865-4f72-8389-84bdb89f1ee6", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "36800-379", "generic_name": "Diphenhydramine Hydrochloride", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Topcare childrens allergy", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "12.5 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "19871215", "listing_expiration_date": "20261231"}