Allergy Relief

Product NDC: 68016-051
Requested package NDC: 68016-051-18
11-digit product format: 680160051
Labeler code: 68016
Product ID: 68016-051_c40a4b73-e885-40a6-a2b2-4c54ed124223
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCl
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: Chain Drug Consortium
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2011-04-25
Marketing end: 0000-00-00
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 13 mg/1
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68016-051	68016-051-18	D	Discontinued by firm		2026-10-05

Adverse event summaries are temporarily unavailable. Other product information remains available.

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68016-051-18	Allergy ReliefChildrens	3 in 1 CARTON	TABLET, CHEWABLE	3		11
68016-051-18	Allergy ReliefChildrens	6 in 1 BLISTER PACK	TABLET, CHEWABLE	6		11

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68016-051	ALLERGY RELIEF CHILDRENS (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [CHAIN DRUG CONSORTIUM]	10	Legacy NDC, 2 package rows	20250429_2df381f1-bace-46c6-831d-7f31c13f0fff.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE	147-24-0	DIPHENHYDRAMINE HYDROCHLORIDE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1049900	diphenhydrAMINE HCl 12.5 MG Chewable Tablet	PSN	2df381f1-bace-46c6-831d-7f31c13f0fff	11
1049900	diphenhydramine hydrochloride 12.5 MG Chewable Tablet	SCD	2df381f1-bace-46c6-831d-7f31c13f0fff	11

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68016-051-18	68016005118	3 BLISTER PACK in 1 CARTON (68016-051-18) > 6 TABLET, CHEWABLE in 1 BLISTER PACK	3 blister pack	2011-04-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Premier Value 44-599-Childrens-Delisted	Chain Drug Consortium \| LNK International, Inc.	2025-07-18	HUMAN OTC DRUG LABEL	11