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

Additional Listing Data#

Finished product
Yes
Brand name base
Sominex Max
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1085945, 1086857

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
63029-505-01Sominex 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 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

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1085945diphenhydrAMINE HCl 50 MG Oral TabletPSNe8f6991f-c47a-4d12-934b-04fdf092dac34
1086857Sominex Maximum Strength 50 MG Oral TabletPSNe8f6991f-c47a-4d12-934b-04fdf092dac34
1086857diphenhydramine hydrochloride 50 MG Oral Tablet [Sominex]SBDe8f6991f-c47a-4d12-934b-04fdf092dac34
1085945diphenhydramine hydrochloride 50 MG Oral TabletSCDe8f6991f-c47a-4d12-934b-04fdf092dac34
1086857Sominex 50 MG Oral TabletSYe8f6991f-c47a-4d12-934b-04fdf092dac34
1086857Sominex Maximum Strength 50 MG Oral TabletSYe8f6991f-c47a-4d12-934b-04fdf092dac34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63029-505-01630290505011 in 1 BOXHistorical
63029-505-076302905050716 in 1 BLISTER PACKHistorical
63029-505-16630290505161 BLISTER PACK in 1 BOX (63029-505-16) / 16 TABLET in 1 BLISTER PACK1 blister pack2012-06-010000-00-00NoNoCurrent