FDA.reportPublic FDA data

Sominex

Product NDC
63029-554
11-digit product format
630290554
Labeler code
63029
Product ID
63029-554_322a3f7f-6a0f-43b9-9819-9ec52e856404
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Medtech Products Inc.
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-06-01
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
2027-12-31
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
Sominex
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TC2D6JAD40Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049630Internal RxNorm lookup
1086986Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f7858ecf-8498-4465-85d8-3e7814737573Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63029-554-01Sominex9 in 1 BOXTABLET, FILM COATED93
63029-554-01Sominex8 in 1 BLISTER PACKTABLET, FILM COATED83
63029-554-16Sominex2 in 1 BOXTABLET, FILM COATED23
63029-554-16Sominex8 in 1 BLISTER PACKTABLET, FILM COATED83
63029-554-32Sominex4 in 1 BOXTABLET, FILM COATED43
63029-554-32Sominex8 in 1 BLISTER PACKTABLET, FILM COATED83

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63029-554SOMINEX (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [MEDTECH PRODUCTS INC.]2Current NDC, Legacy NDC, 6 package rows20241101_f7858ecf-8498-4465-85d8-3e7814737573.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 12 · 236 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RIGHT REMEDIES Maximum Strength Nighttime Sleep-Aid SoftgelDIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.2d64f5c2-dfa9-e5f5-e063-6294a90a07112025-03-19WarningsExact identifier
application number: M010
Sleep Aid Maximum StrengthDIPHENHYDRAMINE HCLHarris Teeter, LLC322a71bb-fc68-4a03-8a24-20cbdbe6d91b2025-03-13WarningsExact identifier
application number: M010
REVASOL SLEEP AIDDIPHENHYDRAMINE HCLRnv LLC30131010-be70-c940-e063-6394a90a190a2025-03-11WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLL.N.K. International, Inc.1a7189ba-2d52-44fc-83a4-b9f6156c62ff2025-03-07WarningsExact identifier
application number: M010
meijer NIGHTTIME Sleep Aid SOFTGELDIPHENHYDRAMINE HYDROCHLORIDEMeijer, Inc.1bede4cd-bf55-8b84-e063-6394a90aa5c92025-02-19WarningsExact identifier
application number: M010
PHARBEDRYLDIPHENHYDRAMINE HCL 50MGUlai Health LLC135293fb-5674-4638-be55-b968cf51257e2025-01-20WarningsExact identifier
application number: M010
Allergy Relief 25 mgDIPHENHYDRAMINE HCL 25MGUlai Health LLC751f13d4-c4d6-47a5-b40d-1563de08c0482025-01-12WarningsExact identifier
application number: M010
RoboCoughDEXTROMETHORPHAN HBRDXM Pharmacuetical, Inc.32fa7a09-8624-44c1-b9e4-8a8f0594292b2025-01-10WarningsExact identifier
application number: M010
SleepAid (Diphenhydramine HCL)DIPHENHYDRAMINE HCLAPNAR PHARMA LPfaaf5d51-d81d-3acc-e053-6294a90ae08f2025-01-09WarningsExact identifier
application number: M010
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.971515fa-b4d2-1197-e053-2995a90a838d2025-01-03WarningsExact identifier
application number: M010
Nighttime Sleep-Aid SoftgelDIPHENHYDRAMINE HYDROCHLORIDECVS PHARMACY, INC8b0fa259-6702-4667-bac6-f7d0b0839ae02025-01-01WarningsExact identifier
application number: M010
Sleep Aid NighttimeDIPHENHYDRAMINE HYDROCHLORIDETOPCO ASSOCIATES LLC9f1c078d-e537-4ec0-8ae9-54c98282be292024-12-31WarningsExact identifier
application number: M010
Discount Drugmart Nighttime Sleep-AidDIPHENHYDRAMINE HCLDiscount Drug Mart, Incd6d77c2e-42b3-48f0-a662-3872155ef34d2024-12-18WarningsExact identifier
application number: M010
Kroger Nighttime Sleep-AidDIPHENHYDRAMINE HCLTHE KROGER CO98437a72-1b98-4301-b92f-0c17b305cf592024-12-18WarningsExact identifier
application number: M010
equate nighttime sleep aidDIPHENHYDRAMINE HYDROCHLORIDEWALMART INC.6e162152-b414-470c-b146-649d998705772024-12-17WarningsExact identifier
application number: M010
Quality Choice Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEChain Drug Marketing Association, Inc.e8b2858b-a737-c500-e053-2995a90adba62024-12-16WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.f99cc210-b946-42a2-9164-8aa5308c54182024-12-11WarningsExact identifier
application number: M010
CalmCo Sleep Aid Gummy BiteDIPHENHYDRAMINE HCLCalmCo LLC0c534cbd-40e6-8af0-e063-6394a90a56052024-12-07WarningsExact identifier
application number: M010
Somnapure Clinical StrengthDIPHENHYDRAMINE HYDROCHLORIDEForce Factor Brands LLC063517c0-bcb1-46dd-85f1-bbb2f24274ef2024-12-06WarningsExact identifier
application number: M010
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEAAA Pharmaceutical, Inc.c280cf02-ebb2-4847-a66d-d02aff3ea0c92024-12-02WarningsExact identifier
application number: M010

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSNf7858ecf-8498-4465-85d8-3e78147375733
1086986Sominex 25 MG Oral TabletPSNf7858ecf-8498-4465-85d8-3e78147375733
1086986diphenhydramine hydrochloride 25 MG Oral Tablet [Sominex]SBDf7858ecf-8498-4465-85d8-3e78147375733
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCDf7858ecf-8498-4465-85d8-3e78147375733
1086986Sominex 25 MG Oral TabletSYf7858ecf-8498-4465-85d8-3e78147375733
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSNf70ce1a6-c334-025e-e053-6294a90ae53f2
1086986Sominex 25 MG Oral TabletPSNf70ce1a6-c334-025e-e053-6294a90ae53f2
1086986diphenhydramine hydrochloride 25 MG Oral Tablet [Sominex]SBDf70ce1a6-c334-025e-e053-6294a90ae53f2
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCDf70ce1a6-c334-025e-e053-6294a90ae53f2
1086986Sominex 25 MG Oral TabletSYf70ce1a6-c334-025e-e053-6294a90ae53f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63029-554-01630290554019 BLISTER PACK in 1 BOX (63029-554-01) / 8 TABLET, FILM COATED in 1 BLISTER PACK9 blister pack2012-06-010000-00-00NoNoCurrent
63029-554-16630290554162 BLISTER PACK in 1 BOX (63029-554-16) / 8 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2012-06-010000-00-00NoNoCurrent
63029-554-32630290554324 BLISTER PACK in 1 BOX (63029-554-32) / 8 TABLET, FILM COATED in 1 BLISTER PACK4 blister pack2012-06-010000-00-00NoNoCurrent