Diphenhydramine HCl
- Product NDC
- 82568-0004
- 11-digit product format
- 825680004
- Labeler code
- 82568
- Product ID
- 82568-0004_365baf41-5399-4fd7-e063-6294a90a81e1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine HCl
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- AARNA USA 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
- 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 | 1020477, 1049909 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82568-0004-1 | Diphenhydramine HCl | 100 in 1 BOTTLE | CAPSULE | 100 | | 4 |
| 82568-0004-2 | Diphenhydramine HCl | 1000 in 1 BOTTLE | CAPSULE | 1000 | | 4 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82568-0004-1 | 82568000401 | 100 CAPSULE in 1 BOTTLE (82568-0004-1) | 100 capsule | 2025-05-30 | No | No | Historical |
| 82568-0004-2 | 82568000402 | 1000 CAPSULE in 1 BOTTLE (82568-0004-2) | 1000 capsule | 2025-05-30 | No | No | Historical |