Sominex Max

Product NDC: 63029-505
11-digit product format: 630290505
Labeler code: 63029
Product ID: 63029-505_dc571463-dbec-4984-ad42-51732470104e
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCl
Dosage form: TABLET
Route: ORAL
Labeler: Medtech Products Inc.
Application: M010
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2012-06-01
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

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	63029-505	63029-505-01	D	Discontinued by firm		2026-08-17

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Additional Listing Data#

Finished product: Yes
Brand name base: Sominex Max
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
1086857	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
e8f6991f-c47a-4d12-934b-04fdf092dac3	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63029-505-01	Sominex Max	1 in 1 BOX	TABLET	1	4
63029-505-07	Sominex Max	16 in 1 BLISTER PACK	TABLET	16	4
63029-505-16	Sominex Max	16 in 1 BLISTER PACK	TABLET	16	4
63029-505-16	Sominex Max	1 in 1 BOX	TABLET	1	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63029-505-07	EA - Each	63029-505	991e5213-f034-46ba-b13e-02f49a654d62	1	2022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	SOMINEX MAX (DIPHENHYDRAMINE HCL) TABLET [MEDTECH PRODUCTS INC.]	1
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	SOMINEX MAX (DIPHENHYDRAMINE HCL) TABLET [MEDTECH PRODUCTS INC.]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	SOMINEX MAX (DIPHENHYDRAMINE HCL) TABLET [MEDTECH PRODUCTS INC.]	1
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	SOMINEX MAX (DIPHENHYDRAMINE HCL) TABLET [MEDTECH PRODUCTS INC.]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	SOMINEX MAX (DIPHENHYDRAMINE HCL) TABLET [MEDTECH PRODUCTS INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SOMINEX MAX (DIPHENHYDRAMINE HCL) TABLET [MEDTECH PRODUCTS INC.]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	SOMINEX MAX (DIPHENHYDRAMINE HCL) TABLET [MEDTECH PRODUCTS INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	SOMINEX MAX (DIPHENHYDRAMINE HCL) TABLET [MEDTECH PRODUCTS INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SOMINEX MAX (DIPHENHYDRAMINE HCL) TABLET [MEDTECH PRODUCTS INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SOMINEX MAX (DIPHENHYDRAMINE HCL) TABLET [MEDTECH PRODUCTS INC.]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SOMINEX MAX (DIPHENHYDRAMINE HCL) TABLET [MEDTECH PRODUCTS INC.]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	SOMINEX MAX (DIPHENHYDRAMINE HCL) TABLET [MEDTECH PRODUCTS INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	SOMINEX MAX (DIPHENHYDRAMINE HCL) TABLET [MEDTECH PRODUCTS INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SOMINEX MAX (DIPHENHYDRAMINE HCL) TABLET [MEDTECH PRODUCTS INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SOMINEX MAX (DIPHENHYDRAMINE HCL) TABLET [MEDTECH PRODUCTS INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63029-505	SOMINEX MAX (DIPHENHYDRAMINE HCL) TABLET [MEDTECH PRODUCTS INC.]	3	Current NDC, Legacy NDC, 4 package rows	20241101_e8f6991f-c47a-4d12-934b-04fdf092dac3.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 1 of 14 · 261 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CVS Nighttime Childrens Cold and Cough Multi-Symptom Relief	CHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE	CVS PHARMACY	d66b1a2e-49b6-473b-acec-2694c73ce8b4	2026-08-19	Warnings	Exact identifier application number: M010
CVS Childrens Nighttime Multi Symptom Cold	ACETAMINOPHEN , DIPHENHYDRAMINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE	CVS PHARMACY	9b244ac8-4ca7-43a0-b328-88f15f0fcc9d	2026-08-19	Warnings	Exact identifier application number: M010
CVS Health Nighttime Sleep-Aid	DIPHENHYDRAMINE HYDROCHLORIDE	CVS Pharmacy,Inc.	a575a914-14a0-442c-a504-ac7a0aa0ac77	2026-08-18	Warnings	Exact identifier application number: M010
CVS Health Nighttime Sleep-Aid	DIPHENHYDRAMINE HYDROCHLORIDE	CVS Pharmacy,Inc.	e8785ba8-e53e-491e-bbfe-04e860f36131	2026-08-18	Warnings	Exact identifier application number: M010
CVS Health Nighttime Sleep-Aid	DIPHENHYDRAMINE HYDROCHLORIDE	CVS Pharmacy,Inc.	9f944edc-a317-4967-ae54-67b5d183591b	2026-08-18	Warnings	Exact identifier application number: M010
SLEEP AID	DIPHENHYDRAMINE HYDROCHLORIDE	Shield Pharmaceuticals Corp	4b6fc81e-e3ba-4a36-834c-82766311aa73	2026-08-17	Warnings	Exact identifier application number: M010
CVS Nighttime Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE AND ACETAMINOPHEN	CVS PHARMACY	333e170e-52cd-4218-8d15-0bf3c5c75cb9	2026-08-14	Warnings	Exact identifier application number: M010
CVS NightTime Cold	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE	CVS PHARMACY	0f0cc40d-7939-4d4d-a931-b4de4070fea1	2026-08-14	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE	Shield Pharmaceuticals Corp	8db277e2-9d98-40b6-8000-a51c57fb4ece	2026-08-14	Warnings	Exact identifier application number: M010
Theraflu Relief Max Strength Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND DEXTROMETHOPHAN HBR	CVS PHARMACY	4b567234-1da9-4e10-a427-877eea2be1c1	2026-08-14	Warnings	Exact identifier application number: M010
CVS Nighttime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	CVS PHARMACY	87d4cfc0-c7b4-42c0-bfa9-96e124e32ed3	2026-08-14	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid Berry Flavor	DIPHENHYDRAMINE HYDROCHLORIDE	WINCO FOODS, LLC	6fb6cfde-30a6-419c-973d-8abdc72611ed	2026-08-07	Warnings	Exact identifier application number: M010
Sleep Aid	DIPHENHYDRAMINE HCL	DOLGENCORP, LLC	2bb3016a-2e03-43fe-a655-45d4ec872c79	2026-08-05	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid Alcohol Free	DIPHENHYDRAMINE HCL	Wal-Mart Stores Inc	6e398d21-6cfa-4f9b-9219-0cd949e88266	2026-08-05	Warnings	Exact identifier application number: M010
Sleep Tabs	DIPHENHYDRAMINE HCL	Major Pharmaceuticals	ff8b7346-5be5-4e76-9ee2-d52fab66f6c5	2026-08-03	Warnings	Exact identifier application number: M010
Mantra	MANTRA SLEEP AID WILD CHERRY	MOREMED INC.	316d11fe-a173-a1dd-e063-6394a90af499	2026-07-27	Warnings	Exact identifier application number: M010
Wal Som Nighttime Sleep Aid	DIPHENHYDRAMINE HCL	Walgreens	ff475a69-dbb2-40a9-b7f4-9c7b7e975d19	2026-07-23	Warnings	Exact identifier application number: M010
Sleep Aid	DIPHENHYDRAMINE HCL	TARGET Corporation	336ac29d-db24-44da-a299-5a4793ae8f6a	2026-07-21	Warnings	Exact identifier application number: M010
Best Choice Childrens Allergy Relief Bubblegum flavor	DIPHENHYDRAMINE HCL	BEST CHOICE (VALU MERCHANDISERS COMPANY)	9bf2d698-8394-46c3-b7a9-e99ab6bb88e4	2026-07-17	Warnings	Exact identifier application number: M010
ADWE dye-free childrens allergy	DIPHENHYDRAMINE HYDROCHLORIDE	RARITAN PHARMACEUTICALS INC	ea3a51af-3025-497f-8cd7-e99391b0d06f	2026-07-17	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	e8f6991f-c47a-4d12-934b-04fdf092dac3	4
1086857	Sominex Maximum Strength 50 MG Oral Tablet	PSN	e8f6991f-c47a-4d12-934b-04fdf092dac3	4
1086857	diphenhydramine hydrochloride 50 MG Oral Tablet [Sominex]	SBD	e8f6991f-c47a-4d12-934b-04fdf092dac3	4
1085945	diphenhydramine hydrochloride 50 MG Oral Tablet	SCD	e8f6991f-c47a-4d12-934b-04fdf092dac3	4
1086857	Sominex 50 MG Oral Tablet	SY	e8f6991f-c47a-4d12-934b-04fdf092dac3	4
1086857	Sominex Maximum Strength 50 MG Oral Tablet	SY	e8f6991f-c47a-4d12-934b-04fdf092dac3	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63029-505-01	63029050501	1 in 1 BOX						Historical
63029-505-07	63029050507	16 in 1 BLISTER PACK						Historical
63029-505-16	63029050516	1 BLISTER PACK in 1 BOX (63029-505-16) / 16 TABLET in 1 BLISTER PACK	1 blister pack	2012-06-01	0000-00-00	No	No	Current