childrens dye free allergy

Generic: diphenhydramine hydrochloride

Labeler: p & l development, llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name childrens dye free allergy
Generic Name diphenhydramine hydrochloride
Labeler p & l development, llc
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 12.5 mg/5mL

Manufacturer
P & L Development, LLC

Identifiers & Regulatory

Product NDC 49580-0293
Product ID 49580-0293_cb18f7c6-b7e5-4609-93f6-8fe61b41ba6e
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2015-02-28

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 495800293
Hyphenated Format 49580-0293

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 childrens dye free 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, PLASTIC in 1 BOX (49580-0293-4) / 118 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

49580-0293-4 1 BOTTLE, PLASTIC in 1 BOX (49580-0293-4) / 118 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

diphenhydramine hydrochloride (12.5 mg/5mL)

Linked Drug Pages (1)

Childrens Dye Free Allergy ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "cb18f7c6-b7e5-4609-93f6-8fe61b41ba6e", "openfda": {"unii": ["TC2D6JAD40"], "rxcui": ["1049906"], "spl_set_id": ["1c4d09ed-4e0f-430d-b17f-6a23f996a55d"], "manufacturer_name": ["P & L Development, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 BOX (49580-0293-4)  / 118 mL in 1 BOTTLE, PLASTIC", "package_ndc": "49580-0293-4", "marketing_start_date": "20150228"}], "brand_name": "Childrens Dye Free Allergy", "product_id": "49580-0293_cb18f7c6-b7e5-4609-93f6-8fe61b41ba6e", "dosage_form": "LIQUID", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "49580-0293", "generic_name": "Diphenhydramine Hydrochloride", "labeler_name": "P & L Development, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Childrens Dye Free Allergy", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "12.5 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20150228", "listing_expiration_date": "20261231"}