Diphenhydramine HCL
- Product NDC
- 68071-3352
- 11-digit product format
- 680713352
- Labeler code
- 68071
- Product ID
- 68071-3352_1ce905e8-9476-0b57-e063-6394a90ab525
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine HCL
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2010-01-27
- 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
- Diphenhydramine HCL
- 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 | 1049909 |
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 |
|---|
| 68071-3352-4 | Diphenhydramine HCL | 4 in 1 BOTTLE | CAPSULE | 4 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3352 | DIPHENHYDRAMINE HCL CAPSULE [NUCARE PHARMACEUTICALS, INC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20240731_5411544e-3c2d-4e42-e054-00144ff8d46c.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 |
|---|
| 68071-3352-4 | 68071335204 | 4 CAPSULE in 1 BOTTLE (68071-3352-4) | 4 capsule | 2017-07-11 | 0000-00-00 | No | No | Current |