OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution
- Product NDC
- 87078-411
- 11-digit product format
- 870780411
- Labeler code
- 87078
- Product ID
- 87078-411_407b7cbb-7ebe-7b7e-e063-6394a90af501
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine HCl
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- MEDWISE LIFESCIENCES INC.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-10-06
- 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
- OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution
- 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 |
|---|
| 87078-411-52 | OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution | 12 in 1 CARTON | SOLUTION | 12 | | 1 |
| 87078-411-52 | OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution | 5 mL in 1 POUCH | SOLUTION | 5 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 87078-411-52 | 87078041152 | 12 POUCH in 1 CARTON (87078-411-52) / 5 mL in 1 POUCH | 12 pouch | 2025-10-06 | No | No | Historical |