adwe dye-free childrens allergy

Generic: diphenhydramine hydrochloride

Labeler: raritan pharmaceuticals inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name adwe dye-free childrens allergy
Generic Name diphenhydramine hydrochloride
Labeler raritan pharmaceuticals inc
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 12.5 mg/5mL

Manufacturer
RARITAN PHARMACEUTICALS INC

Identifiers & Regulatory

Product NDC 68163-710
Product ID 68163-710_3a1d821f-239d-4a4f-e063-6294a90ae3da
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M010
Listing Expiration 2026-12-31
Marketing Start 2021-11-22

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 68163710
Hyphenated Format 68163-710

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 adwe dye-free childrens allergy (source: ndc)
Generic Name diphenhydramine hydrochloride (source: ndc)
Application Number M010 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (68163-710-08) / 236 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

68163-710-08 1 BOTTLE, PLASTIC in 1 CARTON (68163-710-08) / 236 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

diphenhydramine hydrochloride (12.5 mg/5mL)

Linked Drug Pages (1)

ADWE dye-free childrens allergy ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3a1d821f-239d-4a4f-e063-6294a90ae3da", "openfda": {"unii": ["TC2D6JAD40"], "rxcui": ["1049906"], "spl_set_id": ["ea3a51af-3025-497f-8cd7-e99391b0d06f"], "manufacturer_name": ["RARITAN PHARMACEUTICALS INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (68163-710-08)  / 236 mL in 1 BOTTLE, PLASTIC", "package_ndc": "68163-710-08", "marketing_start_date": "20211122"}], "brand_name": "ADWE dye-free childrens allergy", "product_id": "68163-710_3a1d821f-239d-4a4f-e063-6294a90ae3da", "dosage_form": "SYRUP", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "68163-710", "generic_name": "Diphenhydramine hydrochloride", "labeler_name": "RARITAN PHARMACEUTICALS INC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "ADWE dye-free childrens allergy", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "12.5 mg/5mL"}], "application_number": "M010", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20211122", "listing_expiration_date": "20261231"}