FDA.reportPublic FDA data

NDC 63029-505-07 - Sominex Max

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
63029-505
Requested NDC
63029-505-07
Package NDCs from labels
63029-505-07, 63029-505-01, 63029-505-16
Manufacturer
Medtech Products Inc.
Effective date
2025-10-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sominex MaxMedtech Products Inc.2025-10-23HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63029-505-01Sominex Max1 in 1 BOXTABLET14
63029-505-07Sominex Max16 in 1 BLISTER PACKTABLET164
63029-505-16Sominex Max16 in 1 BLISTER PACKTABLET164
63029-505-16Sominex Max1 in 1 BOXTABLET14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63029-505SOMINEX MAX (DIPHENHYDRAMINE HCL) TABLET [MEDTECH PRODUCTS INC.]3Current NDC, Legacy NDC, 4 package rows20241101_e8f6991f-c47a-4d12-934b-04fdf092dac3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63029-505-07EA - Each63029-505991e5213-f034-46ba-b13e-02f49a654d6212022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40SOMINEX MAX (DIPHENHYDRAMINE HCL) TABLET [MEDTECH PRODUCTS INC.]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MSOMINEX MAX (DIPHENHYDRAMINE HCL) TABLET [MEDTECH PRODUCTS INC.]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933SOMINEX MAX (DIPHENHYDRAMINE HCL) TABLET [MEDTECH PRODUCTS INC.]1
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPSOMINEX MAX (DIPHENHYDRAMINE HCL) TABLET [MEDTECH PRODUCTS INC.]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZSOMINEX MAX (DIPHENHYDRAMINE HCL) TABLET [MEDTECH PRODUCTS INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USOMINEX MAX (DIPHENHYDRAMINE HCL) TABLET [MEDTECH PRODUCTS INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKSOMINEX MAX (DIPHENHYDRAMINE HCL) TABLET [MEDTECH PRODUCTS INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSOMINEX MAX (DIPHENHYDRAMINE HCL) TABLET [MEDTECH PRODUCTS INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSOMINEX MAX (DIPHENHYDRAMINE HCL) TABLET [MEDTECH PRODUCTS INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SOMINEX MAX (DIPHENHYDRAMINE HCL) TABLET [MEDTECH PRODUCTS INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASOMINEX MAX (DIPHENHYDRAMINE HCL) TABLET [MEDTECH PRODUCTS INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HSOMINEX MAX (DIPHENHYDRAMINE HCL) TABLET [MEDTECH PRODUCTS INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SOMINEX MAX (DIPHENHYDRAMINE HCL) TABLET [MEDTECH PRODUCTS INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSOMINEX MAX (DIPHENHYDRAMINE HCL) TABLET [MEDTECH PRODUCTS INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSOMINEX MAX (DIPHENHYDRAMINE HCL) TABLET [MEDTECH PRODUCTS INC.]1

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 192 · 3,832 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
Nighttime Sleep Aid Berry FlavorDIPHENHYDRAMINE HYDROCHLORIDERaritan Pharmaceuticals Inc303d7651-9c8f-4a14-9f2c-7181fa0f003e2026-09-09WarningsExact identifier
unii: TC2D6JAD40
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
VICKS ZzzQuil NIGHTTIME SLEEP-AID Diphenhydramine HCl FREE OFDIPHENHYDRAMINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Company01906eed-78ee-f2a1-e063-6294a90a809b2026-09-08WarningsExact identifier
application number: M010
unii: TC2D6JAD40
Nighttime Severe Cold and CoughACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINERARITAN PHARMACEUTICALS INC9819155b-2713-42be-867e-16605e7643d02026-09-08WarningsExact identifier
unii: TC2D6JAD40
Drx Choice childrens allergy chewsDIPHENHYDRAMINE HCLRARITAN PHARMACEUTICALS INCdd2be906-bd0a-437c-9693-54b9391a5da32026-09-05WarningsExact identifier
unii: TC2D6JAD40
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
OilMINERAL OILAtlantic Biologicals Corp.5a82197b-281d-76c0-e063-6294a90a57462026-09-02Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
Nighttime Severe Cold and CoughACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINEKROGER COMPANY7def6781-0881-46bf-ad7a-7a3f23a8d9f72026-09-02WarningsExact identifier
application number: M010
unii: TC2D6JAD40
Sleep AidDIPHENHYDRAMINE HCLTARGET Corporationedfe32b5-9213-4350-9508-2530ee26c5d52026-09-02WarningsExact identifier
application number: M010
unii: TC2D6JAD40
Kroger Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEKroger Companyc5ce0901-a5d7-46c4-8492-5a80c76e85172026-09-02WarningsExact identifier
application number: M010
Maximum Strength Nighttime Cold and FluACETAMINOPHEN , DIPHENHYDRAMINE HCL,PHENYLEPHRINE HCLTHE KROGER CO058b2021-8a61-40b0-8a2e-a784d2b847fb2026-09-02WarningsExact identifier
unii: TC2D6JAD40
KROGER Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEKROGER COMPANYa26d63db-8841-47a4-ae09-ac736d7ec3572026-09-02WarningsExact identifier
application number: M010
unii: TC2D6JAD40
KROGER Dye Free Childrens Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEKROGER COMPANY2bea22e9-34b6-4961-94bb-5600dd90e8912026-09-02WarningsExact identifier
unii: TC2D6JAD40
MAX ALLERGY KIDSDIPHENHYDRAMINE HCLAkron Pharma Inc.96c4ade8-67b1-41e5-8624-fb49090208af2026-09-01WarningsExact identifier
unii: TC2D6JAD40
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLTOP CARE (Topco Associates LLC)923b443d-73cc-4c52-92e4-a075786b1ae32026-09-01WarningsExact identifier
unii: TC2D6JAD40
ACETAMINOPHEN PMACETAMINOPHEN, DIPHENHYDRAMINE HCLAmazon.com Services LLC99a137d6-07eb-43bc-b4b4-1a23041d595e2026-08-31WarningsExact identifier
unii: TC2D6JAD40
BMNP SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro5a58454f-aed6-24ba-e063-6294a90a47fb2026-08-31WarningsExact identifier
unii: ETJ7Z6XBU4
Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEHyVee Inc53157137-b980-45d2-aa10-8c111c0ec2f42026-08-31WarningsExact identifier
unii: TC2D6JAD40
acetaminophen pm extra strengthACETAMINOPHEN, DIPHENHYDRAMINE HCLSam's West Inccff9a730-2241-4e4c-bf6b-a2fa895e24172026-08-31WarningsExact identifier
unii: TC2D6JAD40

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.