Dimetapp
- Product NDC
- 69536-335
- 11-digit product format
- 695360335
- Labeler code
- 69536
- Product ID
- 69536-335_41e82253-443b-2119-e063-6394a90a9912
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen, diphenhydramine hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Foundation Consumer Healthcare
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-06-01
- Substance
- ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
- Active strength
- 320; 12.5 mg/10mL; mg/10mL
- 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
- Dimetapp
- Brand name suffix
- Multi-Symptom Cold and Flu
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 320 mg/10mL |
| DIPHENHYDRAMINE HYDROCHLORIDE | 12.5 mg/10mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, TC2D6JAD40 |
| Rxcui | 2683420 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69536-335-04 | DimetappMulti-Symptom Cold and Flu | 118 mL in 1 BOTTLE | SOLUTION | 118 | | 2 |
| 69536-335-04 | DimetappMulti-Symptom Cold and Flu | 1 in 1 CARTON | SOLUTION | 1 | | 2 |
| 69536-335-08 | DimetappMulti-Symptom Cold and Flu | 2 in 1 CARTON | SOLUTION | 2 | | 2 |
| 69536-335-08 | DimetappMulti-Symptom Cold and Flu | 118 mL in 1 BOTTLE | SOLUTION | 118 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69536-335 | DIMETAPP MULTI-SYMPTOM COLD AND FLU (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [FOUNDATION CONSUMER HEALTHCARE] | 1 | Current NDC, 4 package rows | 20240601_178fe95b-e1ed-43b2-e063-6294a90a7a78.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 |
|---|
| 69536-335-04 | 69536033504 | 1 BOTTLE in 1 CARTON (69536-335-04) / 118 mL in 1 BOTTLE | 1 bottle | 2024-06-01 | No | No | Current |
| 69536-335-08 | 69536033508 | 2 BOTTLE in 1 CARTON (69536-335-08) / 118 mL in 1 BOTTLE | 2 bottle | 2025-11-01 | No | No | Current |