Panadol
- Product NDC
- 0135-7033
- 11-digit product format
- 001357033
- Labeler code
- 0135
- Product ID
- 0135-7033_509dd8bd-dcd2-09e6-e063-6394a90a2d09
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen, dextromethorphan HBr
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Haleon US Holdings LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-04-30
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
- Active strength
- 500; 15 mg/1; mg/1
- Pharmacologic classes
- Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Panadol
- Brand name suffix
- Cold and Flu Day
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 500 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 15 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, 9D2RTI9KYH |
| Rxcui | 247324 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0135-7033-20 | PanadolCold and Flu Day | 2 in 1 CARTON | TABLET | 2 | | 2 |
| 0135-7033-20 | PanadolCold and Flu Day | 10 in 1 BLISTER PACK | TABLET | 10 | | 2 |
| 0135-7033-50 | PanadolCold and Flu Day | 2 in 1 POUCH | TABLET | 2 | | 2 |
| 0135-7033-50 | PanadolCold and Flu Day | 50 in 1 CARTON | TABLET | 50 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0135-7033-20 | 00135703320 | 2 BLISTER PACK in 1 CARTON (0135-7033-20) / 10 TABLET in 1 BLISTER PACK | 2 blister pack | 2026-04-30 | No | No | Historical |
| 0135-7033-50 | 00135703350 | 50 POUCH in 1 CARTON (0135-7033-50) / 2 TABLET in 1 POUCH | 50 pouch | 2026-04-30 | No | No | Historical |