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 108 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diphenhydramine HCl	DIPHENHYDRAMINE HYDROCHLORIDE	Major Pharmaceuticals	1b591e27-b00b-41c8-9fe9-c633aba09134	2025-08-01	Warnings	Exact identifier application number: M012
meijer Nighttime Cold and Flu SOFTGEL	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Meijer, Inc.	377248b6-d64d-8dff-e063-6394a90a43f6	2025-07-31	Warnings	Exact identifier application number: M012
meijer Daytime Cold and Flu SOFTGEL	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Meijer, Inc.	3771f778-7ac9-7108-e063-6394a90a1105	2025-07-31	Warnings	Exact identifier application number: M012
tussin dm	DEXTROMETHORPHAN HBR, GUAIFENESIN	CVS Pharmacy	087d7774-9b0f-44f6-bc1b-4dfbd2f2f6ca	2025-07-31	Warnings	Exact identifier application number: M012
Equate Nasal	OXYMETAZOLINE HCL	Wal-Mart Stores Inc	c38a2783-aed9-466d-8976-59d03a792c04	2025-07-30	Warnings	Exact identifier application number: M012
Quality Choice Throat Soothing Drops Creamy Strawberry	PECTIN	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	3b15d2ea-f784-275d-e063-6394a90a800c	2025-07-29	Warnings	Exact identifier application number: M012
Respiratory Relief	GUAIFENESIN	Schwabe North America, Inc	f683041a-4ff9-42a5-9047-a9a3140a8758	2025-07-29	Warnings	Exact identifier application number: M012
Childrens Robitussin Honey Cough and Chest Congestion DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Haleon US Holdings LLC	b87f700e-3414-463c-80d4-c3dbca89a488	2025-07-29	Warnings	Exact identifier application number: M012
Tussin DM	TUSSIN DM	Allegiant Health	7a2f8d48-3123-4c37-b238-bd7cc4242bb7	2025-07-23	Warnings	Exact identifier application number: M012
Dr. SANA COUGH AND CHEST CONGESTION DM SUGAR FREE	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	GADAL Laboratories, Inc	5fb2438b-8f2d-4af2-9981-42d278d26800	2025-07-23	Warnings	Exact identifier application number: M012
DR. SANA COUGH AND CHEST CONGESTION DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	GADAL Laboratories, Inc	baca0580-4c30-4b94-89fa-a7cf06d4ff25	2025-07-22	Warnings	Exact identifier application number: M012
Defensol D	ACETAMINOPHEN, CHLORPHERINAMINE MALEATE, PHENYLEPHRINE HCI	Menper Distributors, Inc.	f466c660-69eb-4581-81ff-1499fa421d8b	2025-07-22	Warnings	Exact identifier application number: M012
Defensol D Blister Pack	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCI	Menper Distributors, Inc.	0dfcc977-6101-4536-e063-6294a90a7a48	2025-07-22	Warnings	Exact identifier application number: M012
Broncofin	DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Menper Distributors, Inc.	fdf67382-1692-485b-92f1-2cbb8be4fb70	2025-07-22	Warnings	Exact identifier application number: M012
Defensol Adult Syrup	GUAIFENESIN, DEXTROMETHORPHAN HBR	Menper Distributors, Inc.	62acff69-8c40-4a0e-8d56-be2cc14e3d45	2025-07-22	Warnings	Exact identifier application number: M012
Cosedal Drops	DEXTROMETHORPHAN HBR, GUAIFENESIN	Menper Distributors, Inc.	1241d249-ea3b-4d2b-87ed-835d6a2d286a	2025-07-22	Warnings	Exact identifier application number: M012
Berro y Cebolla DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Menper Distributors, Inc.	20107bd9-6d84-4ab5-a0d9-966f1f11d919	2025-07-22	Warnings	Exact identifier application number: M012
Defensol-ito	DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE	Menper Distributors, Inc	a7c7a60d-d49f-4239-92f7-714eac7eb0c5	2025-07-22	Warnings	Exact identifier application number: M012
Bisolvine Children	GUAIFENESIN, DEXTROMETHORPHAN	MENPER DISTRIBUTORS INC.	896a5443-e3d2-4af7-9e27-f1c1899ce038	2025-07-22	Warnings	Exact identifier application number: M012
Bisolvine Aloe-Miel	DEXTROMETHORPHAN, GUAIFENESIN	MENPER DISTRIBUTORS INC.	34801c79-ce88-492f-808e-b639e8601607	2025-07-22	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