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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sominex
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | TC2D6JAD40 |
| Rxcui | 1049630, 1086986 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63029-554-01 | Sominex | 9 in 1 BOX | TABLET, FILM COATED | 9 | | 3 |
| 63029-554-01 | Sominex | 8 in 1 BLISTER PACK | TABLET, FILM COATED | 8 | | 3 |
| 63029-554-16 | Sominex | 2 in 1 BOX | TABLET, FILM COATED | 2 | | 3 |
| 63029-554-16 | Sominex | 8 in 1 BLISTER PACK | TABLET, FILM COATED | 8 | | 3 |
| 63029-554-32 | Sominex | 4 in 1 BOX | TABLET, FILM COATED | 4 | | 3 |
| 63029-554-32 | Sominex | 8 in 1 BLISTER PACK | TABLET, FILM COATED | 8 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63029-554 | SOMINEX (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [MEDTECH PRODUCTS INC.] | 2 | Current NDC, Legacy NDC, 6 package rows | 20241101_f7858ecf-8498-4465-85d8-3e7814737573.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63029-554-01 | 63029055401 | 9 BLISTER PACK in 1 BOX (63029-554-01) / 8 TABLET, FILM COATED in 1 BLISTER PACK | 9 blister pack | 2012-06-01 | 0000-00-00 | No | No | Current |
| 63029-554-16 | 63029055416 | 2 BLISTER PACK in 1 BOX (63029-554-16) / 8 TABLET, FILM COATED in 1 BLISTER PACK | 2 blister pack | 2012-06-01 | 0000-00-00 | No | No | Current |
| 63029-554-32 | 63029055432 | 4 BLISTER PACK in 1 BOX (63029-554-32) / 8 TABLET, FILM COATED in 1 BLISTER PACK | 4 blister pack | 2012-06-01 | 0000-00-00 | No | No | Current |