Diphenhydramine HCl
- Product NDC
- 68071-3877
- 11-digit product format
- 680713877
- Labeler code
- 68071
- Product ID
- 68071-3877_47acca00-4497-1432-e063-6294a90a7bc8
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine HCl
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-12-06
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Diphenhydramine HCl
- Listing expiration
- 2027-12-31
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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-3877-3 | Diphenhydramine HCl | 30 in 1 BOTTLE | CAPSULE | 30 | | 3 |
| 68071-3877-5 | Diphenhydramine HCl | 15 in 1 BOTTLE | CAPSULE | 15 | | 3 |
| 68071-3877-6 | Diphenhydramine HCl | 60 in 1 BOTTLE | CAPSULE | 60 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3877-3 | 68071387703 | 30 CAPSULE in 1 BOTTLE (68071-3877-3) | 30 capsule | 2025-08-12 | No | No | Historical |
| 68071-3877-5 | 68071387705 | 15 CAPSULE in 1 BOTTLE (68071-3877-5) | 15 capsule | 2026-01-05 | No | No | Historical |
| 68071-3877-6 | 68071387706 | 60 CAPSULE in 1 BOTTLE (68071-3877-6) | 60 capsule | 2025-08-14 | No | No | Historical |