Sleep Tabs

Product NDC: 69168-247
11-digit product format: 691680247
Labeler code: 69168
Product ID: 69168-247_51f0777e-6c05-48ee-bb31-a53f18c04627
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCl Tablets
Dosage form: TABLET
Route: ORAL
Labeler: Allegiant Health
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-04-28
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: 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: Sleep Tabs
Brand name suffix: For Nighttime use
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	25 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
1049630	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
566e40b1-e9d7-44e4-b971-eef2b7cf0a7d	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
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
69168-247-24	2020-03-13	C162847	48780-1	9d75b9d0-48c4-f424-e053-dadaa90a57ce	Drug Facts
69168-247-24	2020-01-31	C162847	48780-1	9d75b9d0-48c4-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69168-247-24	Sleep TabsFor Nighttime use	24 in 1 BOTTLE, UNIT-DOSE	TABLET	24		5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	SLEEP TABS FOR NIGHTTIME USE (DIPHENHYDRAMINE HCL TABLETS) TABLET [ALLEGIANT HEALTH]	1
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	SLEEP TABS FOR NIGHTTIME USE (DIPHENHYDRAMINE HCL TABLETS) TABLET [ALLEGIANT HEALTH]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SLEEP TABS FOR NIGHTTIME USE (DIPHENHYDRAMINE HCL TABLETS) TABLET [ALLEGIANT HEALTH]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SLEEP TABS FOR NIGHTTIME USE (DIPHENHYDRAMINE HCL TABLETS) TABLET [ALLEGIANT HEALTH]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	SLEEP TABS FOR NIGHTTIME USE (DIPHENHYDRAMINE HCL TABLETS) TABLET [ALLEGIANT HEALTH]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SLEEP TABS FOR NIGHTTIME USE (DIPHENHYDRAMINE HCL TABLETS) TABLET [ALLEGIANT HEALTH]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	SLEEP TABS FOR NIGHTTIME USE (DIPHENHYDRAMINE HCL TABLETS) TABLET [ALLEGIANT HEALTH]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SLEEP TABS FOR NIGHTTIME USE (DIPHENHYDRAMINE HCL TABLETS) TABLET [ALLEGIANT HEALTH]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SLEEP TABS FOR NIGHTTIME USE (DIPHENHYDRAMINE HCL TABLETS) TABLET [ALLEGIANT HEALTH]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	SLEEP TABS FOR NIGHTTIME USE (DIPHENHYDRAMINE HCL TABLETS) TABLET [ALLEGIANT HEALTH]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SLEEP TABS FOR NIGHTTIME USE (DIPHENHYDRAMINE HCL TABLETS) TABLET [ALLEGIANT HEALTH]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69168-247	SLEEP TABS FOR NIGHTTIME USE (DIPHENHYDRAMINE HCL TABLETS) TABLET [ALLEGIANT HEALTH]	5	Current NDC, Legacy NDC, 1 package rows	20231114_566e40b1-e9d7-44e4-b971-eef2b7cf0a7d.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 9 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CVS Childrens Cold and Allergy	BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	CVS PHARMACY, INC.	f4020c08-29f6-4609-834e-191ce6885130	2026-08-14	Warnings	Exact identifier application number: M012
CVS Severe Cough, Flu Plus Sore Throat Honey	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	CVS PHARMACY	95203001-7ca6-4513-83a3-9ef17855bc0f	2026-08-14	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Relief	ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	CVS PHARMACY	81d26e9c-b713-4fb3-b0a5-68526bad230e	2026-08-14	Warnings	Exact identifier application number: M012
nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Amazon.com Services LLC	212acd54-6ff0-446a-a3bb-3b40e1279711	2026-08-13	Warnings	Exact identifier application number: M012
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Walgreen Company	e9d0b6f9-e9f3-431c-9f34-4d63108282a1	2026-08-13	Warnings	Exact identifier application number: M012
Best Health Caramel Apple Cough Drops	MENTHOL	Bestco	58eee9b4-d696-995f-e063-6294a90a5db0	2026-08-13	Warnings	Exact identifier application number: M012
Best Health Pumpkin Spice Cough Drops	MENTHOL	Bestco	58ef6619-9087-5f41-e063-6294a90a7da6	2026-08-13	Warnings	Exact identifier application number: M012
Best Health Bourbon Honey Cough Drops	MENTHOL	Bestco	58efdf29-83ea-03b9-e063-6294a90ad306	2026-08-13	Warnings	Exact identifier application number: M012
daytime nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL	Amazon.com Services LLC	9bb6bbd5-508e-4781-ad1c-69ccf0a5f13e	2026-08-13	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Amazon.com Services LLC	1e3c81b0-05de-4c4a-8579-f301f14626b3	2026-08-13	Warnings	Exact identifier application number: M012
Tussin DM Daytime Nighttime	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	d59f6c64-8311-48ba-90d1-8000b04bfcda	2026-08-13	Warnings	Exact identifier application number: M012
TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS DAY PLUS NIGHT	ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Kenvue Brands LLC	1c5578e6-7e67-c467-e063-6294a90a6e0b	2026-08-12	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Amazon.com Services LLC	f95220c5-e55c-4271-a267-d004ad2447bf	2026-08-12	Warnings	Exact identifier application number: M012
CVS PHARMACY Childrens Allergy Chews	DIPHENHYDRAMINE HCL	CVS PHARMACY, INC.	569b8efa-8458-49f7-a665-6b7016a10505	2026-08-12	Warnings	Exact identifier application number: M012
CVS PHARMACY DYE FREE Childrens Allergy Chews	DIPHENHYDRAMINE HCL	CVS PHARMACY, INC.	e6671e8b-653a-4f4e-b6f3-e31fcd14fbd7	2026-08-12	Warnings	Exact identifier application number: M012
Cold and Flu Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	af35c833-316a-4d21-bd3a-9b71558cadbf	2026-08-12	Warnings	Exact identifier application number: M012
Tussin DM Max	DEXTROMETHORPHAN HBR, GUAIFENESIN	Wal-Mart Stores Inc	cc77f3a6-48ce-41b5-bf4e-5ed7d8c69e2c	2026-08-11	Warnings	Exact identifier application number: M012
Best Health Maple Spice Cough Drops	MENTHOL	Bestco	58cfdacb-c713-220f-e063-6394a90acbfc	2026-08-11	Warnings	Exact identifier application number: M012
7 Select Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN	7-ELEVEN	f9475972-0cbb-45c5-9e49-09569f1665a7	2026-08-11	Warnings	Exact identifier application number: M012
Allergy Relief Childrens	DIPHENHYDRAMINE HCL	L.N.K. International, Inc.	6ec5445b-a1f2-47ba-99f7-5a4a6d0c29e3	2026-08-10	Warnings	Exact identifier application number: M012

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	566e40b1-e9d7-44e4-b971-eef2b7cf0a7d	5
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	566e40b1-e9d7-44e4-b971-eef2b7cf0a7d	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69168-247-24	69168024724	24 TABLET in 1 BOTTLE, UNIT-DOSE (69168-247-24)	24 tablet	2015-04-28	0000-00-00	No	No	Current