Diphenhydramine HCl Oral Solution
- Product NDC
- 81033-029
- 11-digit product format
- 810330029
- Labeler code
- 81033
- Product ID
- 81033-029_2f871005-de4e-8b2a-e063-6394a90aa43a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine HCl Oral Solution
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Kesin Pharma Corporation
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-03-04
- Substance
- DIPHENHYDRAMINE HCL
- 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 Oral Solution
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DIPHENHYDRAMINE HCL | 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 |
|---|
| 81033-029-16 | Diphenhydramine HCl Oral Solution | 473 mL in 1 BOTTLE | SOLUTION | 473 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 81033-029 | DIPHENHYDRAMINE HCL ORAL SOLUTION SOLUTION [KESIN PHARMA CORPORATION] | 1 | Current NDC, 1 package rows | 20250330_2f871005-de4d-8b2a-e063-6394a90aa43a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 81033-029-16 | 81033002916 | 473 mL in 1 BOTTLE (81033-029-16) | 473 ml | 2025-03-04 | No | No | Current |