Home NDC 51316-153 CVS PHARMACY
Product NDC 51316-153
11-digit product format 513160153
Labeler code 51316
Product ID 51316-153_8c01c5fa-7acb-4ab3-bdf7-75bfc8e83e7f
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine HCl
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler CVS PHARMACY, INC.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-03-03
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 12.5 mg/1
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base CVS PHARMACY
Brand name suffix DYE FREE Childrens Allergy Chews
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination TC2D6JAD40 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1049900 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51316-153-18 CVS PHARMACYDYE FREE Childrens Allergy Chews 6 in 1 BLISTER PACK TABLET, CHEWABLE 6 2 51316-153-18 CVS PHARMACYDYE FREE Childrens Allergy Chews 3 in 1 CARTON TABLET, CHEWABLE 3 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51316-153 CVS PHARMACY DYE FREE CHILDRENS ALLERGY CHEWS (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [CVS PHARMACY, INC.] 1 Current NDC, 2 package rows 20250321_e6671e8b-653a-4f4e-b6f3-e31fcd14fbd7.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 74 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 51316-153-18 51316015318 3 BLISTER PACK in 1 CARTON (51316-153-18) / 6 TABLET, CHEWABLE in 1 BLISTER PACK 3 blister pack 2025-03-03 No No Current