DIPHENHYDRAMINE HYDROCHLORIDE
- Product NDC
- 0121-0489
- 11-digit product format
- 001210489
- Labeler code
- 0121
- Product ID
- 0121-0489_b7eb09fa-58fb-4c3f-ad65-a04965bc52b0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DIPHENHYDRAMINE HYDROCHLORIDE
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- PAI Holdings, LLC dba PAI Pharma
- Application
- ANDA087513
- Marketing category
- ANDA
- Marketing start
- 1982-02-10
- 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 HYDROCHLORIDE
- 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 |
|---|
| 0121-0489-00 | DIPHENHYDRAMINE HYDROCHLORIDE | 10 in 1 CASE | SOLUTION | 10 | | 12 |
| 0121-0489-00 | DIPHENHYDRAMINE HYDROCHLORIDE | 10 in 1 TRAY | SOLUTION | 10 | | 12 |
| 0121-0489-05 | DIPHENHYDRAMINE HYDROCHLORIDE | 5 mL in 1 CUP, UNIT-DOSE | SOLUTION | 5 | | 12 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | ACTIVE INGREDIENT | TC2D6JAD40 | DIPHENHYDRAMINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 2 | |
| DIPHENHYDRAMINE | ACTIVE MOIETY | 8GTS82S83M | DIPHENHYDRAMINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 2 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | DIPHENHYDRAMINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 2 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | DIPHENHYDRAMINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 2 | |
| D&C RED NO. 33 | INACTIVE INGREDIENT | 9DBA0SBB0L | DIPHENHYDRAMINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 2 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | DIPHENHYDRAMINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 2 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | DIPHENHYDRAMINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 2 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | DIPHENHYDRAMINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | DIPHENHYDRAMINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0121-0489 | DIPHENHYDRAMINE HYDROCHLORIDE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA] | 12 | Current NDC, Legacy NDC, 3 package rows | 20240410_6fe6fe2d-4405-4e7a-a2ed-5eb367d52842.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 |
|---|
| 0121-0489-00 | 00121048900 | 10 TRAY in 1 CASE (0121-0489-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0489-05) | 10 tray | 1982-02-10 | 0000-00-00 | No | No | Current |
| 0121-0489-04 | 00121048904 | 118 mL in 1 BOTTLE (0121-0489-04) | 118 ml | 2019-08-29 | 0000-00-00 | No | No | Current |
| 0121-0489-05 | 00121048905 | 5 mL in 1 CUP, UNIT-DOSE | 5 ml | | | | | Historical |
| 0121-0489-10 | 00121048910 | 10 TRAY in 1 CASE (0121-0489-10) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE | 10 tray | 1982-02-10 | 0000-00-00 | No | No | Current |