Allergy Relief

Product NDC: 68210-4127
Requested package NDC: 68210-4127-1
11-digit product format: 682104127
Labeler code: 68210
Product ID: 68210-4127_ee8b97f2-2e07-d9ca-e053-2995a90ab69b
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Spirit Pharmaceutical LLC
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2021-04-27
Marketing end: 0000-00-00
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 25 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	68210-4127	68210-4127-1	I	Inactivated by FDA		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68210-4127-1	2025-01-30	C162847	48780-1	2cef2736-850f-d83d-e063-dadaa90ab31f	Allergy Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68210-4127-1	Allergy Relief	1 in 1 CARTON	TABLET, FILM COATED	1		5
68210-4127-1	Allergy Relief	36 in 1 BOTTLE	TABLET, FILM COATED	36		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68210-4127	ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [SPIRIT PHARMACEUTICAL LLC]	5	Legacy NDC, 2 package rows	20231208_e8dbfb92-ffed-4594-b9eb-9d64dc117c42.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1049630	diphenhydrAMINE HCl 25 MG Oral Tablet	PSN	e8dbfb92-ffed-4594-b9eb-9d64dc117c42	5
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	e8dbfb92-ffed-4594-b9eb-9d64dc117c42	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68210-4127-1	68210412701	1 BOTTLE in 1 CARTON (68210-4127-1) > 36 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2021-04-27	0000-00-00	No	No	Current