Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Doxylamine Succinate
- Product NDC
- 55629-016
- 11-digit product format
- 556290016
- Labeler code
- 55629
- Product ID
- 55629-016_565b9a99-fa8f-47de-bf6a-6496657b56d4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Doxylamine Succinate
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- ONE2ZEE LIMITED LIABILITY COMPANY
- Application
- part341
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2021-03-02
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; DOXYLAMINE SUCCINATE
- Active strength
- 325 mg/1; mg/1; mg/1; mg/1
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 55629-016-01 | 2025-01-30 | C162847 | 48780-1 | f386c64a-422f-0266-e053-dadaa90a7c1a | Nighttime Severe Cold and Flu capsule, liquid filled (Acetaminophen 325mg, Dextromethorphan HBr 10mg, Phenylephrine HCl 5mg, Doxylamine Succinate 6.25 mg) |
| 55629-016-01 | 2023-03-25 | C162847 | 48780-1 | f386c64a-422f-0266-e053-dadaa90a7c1a | Nighttime Severe Cold and Flu capsule, liquid filled (Acetaminophen 325mg, Dextromethorphan HBr 10mg, Phenylephrine HCl 5mg, Doxylamine Succinate 6.25 mg) |
| 55629-016-01 | 2023-01-30 | C162847 | 48780-1 | f386c64a-422f-0266-e053-dadaa90a7c1a | Nighttime Severe Cold and Flu capsule, liquid filled (Acetaminophen 325mg, Dextromethorphan HBr 10mg, Phenylephrine HCl 5mg, Doxylamine Succinate 6.25 mg) |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55629-016-01 | Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Doxylamine Succinate | 48 in 1 CARTON | CAPSULE, LIQUID FILLED | 48 | | 2 |
| 55629-016-02 | Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Doxylamine Succinate | 300 in 1 POUCH | CAPSULE, LIQUID FILLED | 300 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55629-016 | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DOXYLAMINE SUCCINATE CAPSULE, LIQUID FILLED [ONE2ZEE LIMITED LIABILITY COMPANY] | 2 | Legacy NDC, 2 package rows | 20230326_bc11b349-9e1c-4e3c-80d2-07749a67391e.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 |
|---|
| 55629-016-01 | 55629001601 | 48 POUCH in 1 CARTON (55629-016-01) > 300 CAPSULE, LIQUID FILLED in 1 POUCH (55629-016-02) | 48 pouch | 2021-03-02 | 0000-00-00 | No | No | Current |
| 55629-016-02 | 55629001602 | 300 in 1 POUCH | | | | | | Historical |