NIGHTTIME SLEEP AID

Product NDC: 68210-4131
Requested package NDC: 68210-4131-1
11-digit product format: 682104131
Labeler code: 68210
Product ID: 68210-4131_ee8efe74-df78-41b8-e053-2a95a90ac2bc
Type: HUMAN OTC DRUG
Nonproprietary name: DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: SPIRIT PHARMACEUTICALS LLC
Application: part338
Marketing category: OTC MONOGRAPH 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	68210-4131	68210-4131-1	I	Inactivated by FDA		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
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68210-4131-1	NIGHTTIME SLEEP AID	12 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	12		5
68210-4131-1	NIGHTTIME SLEEP AID	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1		5

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68210-4131	NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS LLC]	5	Legacy NDC, 2 package rows	20241215_3f7f3feb-7a7d-4895-875e-c40be9bc5355.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
1049909	diphenhydrAMINE HCl 25 MG Oral Capsule	PSN	3f7f3feb-7a7d-4895-875e-c40be9bc5355	5
1049909	diphenhydramine hydrochloride 25 MG Oral Capsule	SCD	3f7f3feb-7a7d-4895-875e-c40be9bc5355	5

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68210-4131-1	68210413101	1 BLISTER PACK in 1 CARTON (68210-4131-1) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	1 blister pack	2021-04-27	0000-00-00	No	No	Current