Somnapure
- Product NDC
- 69721-005
- 11-digit product format
- 697210005
- Labeler code
- 69721
- Product ID
- 69721-005_35de71a0-7e1c-45fb-97d1-ddf485df6e3c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine Hydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Force Factor Brands LLC
- Application
- M010
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2018-03-20
- 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
- Somnapure
- Brand name suffix
- Clinical Strength
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | TC2D6JAD40 |
| Rxcui | 1085945, 1609070 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69721-005-30 | SomnapureClinical Strength | 1 in 1 CARTON | TABLET, COATED | 1 | | 4 |
| 69721-005-30 | SomnapureClinical Strength | 30 in 1 BOTTLE | TABLET, COATED | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69721-005 | SOMNAPURE CLINICAL STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [FORCE FACTOR BRANDS LLC] | 4 | Current NDC, Legacy NDC, 2 package rows | 20241210_063517c0-bcb1-46dd-85f1-bbb2f24274ef.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 |
|---|
| 69721-005-30 | 69721000530 | 1 BOTTLE in 1 CARTON (69721-005-30) / 30 TABLET, COATED in 1 BOTTLE | 1 bottle | 2018-03-20 | 0000-00-00 | No | No | Current |