Somnapure

Product NDC: 69721-005
11-digit product format: 697210005
Labeler code: 69721
Product ID: 69721-005_35de71a0-7e1c-45fb-97d1-ddf485df6e3c
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine Hydrochloride
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Force Factor Brands LLC
Application: M010
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-03-20
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 50 mg/1
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
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: Somnapure
Brand name suffix: Clinical Strength
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	50 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1085945	Internal RxNorm lookup
1609070	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
063517c0-bcb1-46dd-85f1-bbb2f24274ef	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
69721-005-30	2022-02-01	C162847	48780-1	d6a99b39-9a41-a426-e053-dadaa90af4c2	Somnapure Clinical Strength
69721-005-30	2022-01-28	C162847	48780-1	d6a99b39-9a41-a426-e053-dadaa90af4c2	Somnapure Clinical Strength

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69721-005-30	SomnapureClinical Strength	1 in 1 CARTON	TABLET, COATED	1		4
69721-005-30	SomnapureClinical Strength	30 in 1 BOTTLE	TABLET, COATED	30		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69721-005	SOMNAPURE CLINICAL STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [FORCE FACTOR BRANDS LLC]	4	Current NDC, Legacy NDC, 2 package rows	20241210_063517c0-bcb1-46dd-85f1-bbb2f24274ef.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 11 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nighttime Sleep Aid	DIPHENHYDRAMINE HCL	H E B	d5189048-5eed-4ec4-8c4a-4a167728c4e7	2024-10-16	Warnings	Exact identifier application number: M010
berkley and jensen sleep aid	DIPHENHYDRAMINE HCL	BJWC	e31917a1-e72d-4f71-893f-43046169a32d	2024-10-16	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE	Chain Drug Marketing Association	5fab9bd4-66d7-4356-a778-8900b2e270e2	2024-10-11	Warnings	Exact identifier application number: M010
Sleep Aid NightTime	DIPHENHYDRAMINE HCL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	5b005bfc-f588-4abc-8bb1-4691b40448cd	2024-10-07	Warnings	Exact identifier application number: M010
Sominex	DIPHENHYDRAMINE HYDROCHLORIDE	Navajo Manufacturing Company Inc.	f70ce1a6-c334-025e-e053-6294a90ae53f	2024-10-03	Warnings	Exact identifier application number: M010
meijer NIGHTTIME Sleep Aid CAPLET	DIPHENHYDRAMINE HYDROCHLORIDE	Meijer, Inc.	1c2b57b3-92cb-256b-e063-6394a90ad41b	2024-09-09	Warnings	Exact identifier application number: M010
Up and Up Nighttime Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE	Target Corporation	0ab5a374-d565-4385-bee3-538a8f09b19e	2024-08-15	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	8d985ad7-71b9-493f-9b9a-d6ef280f72dd	2024-08-12	Warnings	Exact identifier application number: M010
Rest Simply	DIPHENHYDRAMINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	3618eb73-6929-4ca5-833d-265b006f15f9	2024-08-12	Warnings	Exact identifier application number: M010
careone nighttime sleep aid	DIPHENHYDRAMINE HYDROCHLORIDE	American Sales Company	14803f99-52c7-4324-b64c-971906144739	2024-07-17	Warnings	Exact identifier application number: M010
Betr sleep aid	DIPHENHYDRAMINE HYDROCHLORIDE	Live Betr LLC	8c2d5514-62c1-4e98-8412-20534365b934	2024-07-17	Warnings	Exact identifier application number: M010
topcare sleep aid nighttime	DIPHENHYDRAMINE HYDROCHLORIDE	Topco Associates LLC	30284271-0411-4abf-bc62-d956dc794432	2024-07-17	Warnings	Exact identifier application number: M010
dg health sleep aid	DIPHENHYDRAMINE HYDROCHLORIDE	Dolgencorp Inc	038c1b4e-43f5-4370-896b-97da1b0a89ca	2024-07-17	Warnings	Exact identifier application number: M010
good sense nighttime sleep aid	DIPHENHYDRAMINE HYDROCHLORIDE	L. Perrigo Company	ba2adc30-0301-4d53-bce6-fc8b7e34b076	2024-07-10	Warnings	Exact identifier application number: M010
Sleep Aid	SLEEP AID	Good Sense	c1481fad-9b32-4f84-8f03-4b4fa5edc866	2024-06-18	Warnings	Exact identifier application number: M010
Sleep Aid Maximum Strength	DIPHENHYDRAMINE HCL	QUALITY CHOICE (Chain Drug Marketing Association)	29b49616-ee5a-4574-81f1-0052addb8f66	2024-04-22	Warnings	Exact identifier application number: M010
Sleep Aid Maximum Strength	DIPHENHYDRAMINE HCL	QUALITY CHOICE (Chain Drug Marketing Association)	b8757d18-6c7d-45de-925a-e2814625f749	2024-04-22	Warnings	Exact identifier application number: M010
EZ Nite Sleep	DIPHENHYRAMINE HYDROCHLORIDE	KROGER COMPANY	0fec16a4-b4eb-8f8f-e063-6394a90a7327	2024-04-17	Warnings	Exact identifier application number: M010
Sleep Aid Nighttime	DIPHENHYDRAMINE HCL	CVS Pharmacy	db951d14-ba8b-4d56-8264-2b8ce84a854c	2024-03-07	Warnings	Exact identifier application number: M010
Sleep Aid	DIPHENHYDRAMINE HCL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	e0da439f-7e23-4e60-8d16-b607aa41ed17	2024-02-28	Warnings	Exact identifier application number: M010

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
1085945	diphenhydrAMINE HCl 50 MG Oral Tablet	PSN	063517c0-bcb1-46dd-85f1-bbb2f24274ef	4
1609070	Somnapure Clinical Strength 50 MG Oral Tablet	PSN	063517c0-bcb1-46dd-85f1-bbb2f24274ef	4
1609070	diphenhydramine hydrochloride 50 MG Oral Tablet [Somnapure]	SBD	063517c0-bcb1-46dd-85f1-bbb2f24274ef	4
1085945	diphenhydramine hydrochloride 50 MG Oral Tablet	SCD	063517c0-bcb1-46dd-85f1-bbb2f24274ef	4
1609070	Somnapure 50 MG Oral Tablet	SY	063517c0-bcb1-46dd-85f1-bbb2f24274ef	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69721-005-30	69721000530	1 BOTTLE in 1 CARTON (69721-005-30) / 30 TABLET, COATED in 1 BOTTLE	1 bottle	2018-03-20	0000-00-00	No	No	Current