Diphenhydramine HCl
- Product NDC
- 0121-0865
- 11-digit product format
- 001210865
- Labeler code
- 0121
- Product ID
- 0121-0865_d56f4fe1-e90c-4e35-a488-12c93938a3dd
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- diphenhydramine hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- PAI Holdings, LLC dba PAI Pharma
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2020-06-18
- Substance
- DIPHENHYDRAMINE HYDROCHLORIDE
- Active strength
- 12.5 mg/5mL
- 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 | 12.5 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | TC2D6JAD40 |
| Rxcui | 1049906 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0121-0865-00 | Diphenhydramine HCl | 10 in 1 CASE | SOLUTION | 10 | | 5 |
| 0121-0865-00 | Diphenhydramine HCl | 10 in 1 TRAY | SOLUTION | 10 | | 5 |
| 0121-0865-05 | Diphenhydramine HCl | 5 mL in 1 CUP, UNIT-DOSE | SOLUTION | 5 | | 5 |
| 0121-0865-30 | Diphenhydramine HCl | 10 in 1 TRAY | SOLUTION | 10 | | 5 |
| 0121-0865-30 | Diphenhydramine HCl | 3 in 1 CASE | SOLUTION | 3 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0121-0865 | DIPHENHYDRAMINE HCL (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA] | 5 | Current NDC, Legacy NDC, 5 package rows | 20240911_3c3e0dc8-cddd-4f46-9b68-19bac00c07cc.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 |
|---|
| 0121-0865-00 | 00121086500 | 10 TRAY in 1 CASE (0121-0865-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0865-05) | 10 tray | 2020-06-18 | 0000-00-00 | No | No | Current |
| 0121-0865-05 | 00121086505 | 5 mL in 1 CUP, UNIT-DOSE | 5 ml | | | | | Historical |
| 0121-0865-30 | 00121086530 | 3 TRAY in 1 CASE (0121-0865-30) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0865-05) | 3 tray | 2020-06-18 | 0000-00-00 | No | No | Current |