Theraflu
- Product NDC
- 0067-6803
- 11-digit product format
- 000676803
- Labeler code
- 0067
- Product ID
- 0067-6803_10682cca-1329-1e41-e063-6394a90a7e21
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN, DIPHENHYDRAMINE HCl, PHENYLEPHRINE HCl
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- Haleon US Holdings LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-01-20
- Substance
- ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 650; 25; 10 mg/237mL; mg/237mL; mg/237mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Theraflu
- Brand name suffix
- Severe Cold Relief Nighttime
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 650 mg/237mL |
| DIPHENHYDRAMINE HYDROCHLORIDE | 25 mg/237mL |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/237mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| TC2D6JAD40 | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1659960 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4daca846-8511-4303-9e6c-9469f7f260ba | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0067-6803-02 | Theraflu Severe Cold Relief Daytime and Theraflu Severe Cold Relief Nighttime | 6 in 1 CARTON | POWDER, FOR SOLUTION | 25 mg in 237mL | 2 | |
| 0067-6803-02 | Theraflu Severe Cold Relief Daytime and Theraflu Severe Cold Relief Nighttime | 237 mL in 1 PACKET | POWDER, FOR SOLUTION | 1422 mL | 25 mg in 237mL | 2 |
| 0067-6803-02 | TherafluSevere Cold Relief Nighttime | 237 mL in 1 PACKET | POWDER, FOR SOLUTION | 237 | 1 | |
| 0067-6803-02 | TherafluSevere Cold Relief Nighttime | 6 in 1 CARTON | POWDER, FOR SOLUTION | 6 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0067-6803 | THERAFLU SEVERE COLD RELIEF DAYTIME AND THERAFLU SEVERE COLD RELIEF NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL) KIT [HALEON US HOLDINGS LLC] | 2 | Current NDC | 20240201_e5ef7b85-feee-44a7-bd0e-ed91352c7434.zip |
| 0067-6803 | THERAFLU SEVERE COLD RELIEF NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [HALEON US HOLDINGS LLC] | 1 | Current NDC, 2 package rows | 20240203_4daca846-8511-4303-9e6c-9469f7f260ba.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Cough Drops | MENTHOL | United Natural Foods, Inc. | f9f0d020-e031-245e-e053-6294a90addb5 | 2024-10-08 | Warnings | M012 |
| Cough Drops | MENTHOL | United Natural Foods, Inc. | fb7ee463-8003-a306-e053-6294a90a8259 | 2024-10-08 | Warnings | M012 |
| Cough Drops | MENTHOL | United Natural Foods, Inc. | fb7e4a84-d2c2-65e5-e053-6394a90a0c72 | 2024-10-08 | Warnings | M012 |
| Cough Drops | CHERRY | United Natural Foods, Inc. | f9f0e853-6997-a49b-e053-6294a90aa4b8 | 2024-10-08 | Warnings | M012 |
| Cough Drops | MENTHOL | United Natural Foods, Inc. | fb7fa728-911d-aaf0-e053-6394a90ace31 | 2024-10-08 | Warnings | M012 |
| Cough Drops | MENTHOL | United Natural Foods, Inc. | fb7f3b84-1e61-eadf-e053-6394a90a9e5c | 2024-10-08 | Warnings | M012 |
| Cough Drops | MENTHOL | United Natural Foods, Inc. | fb7f515f-7302-d153-e053-6394a90a0834 | 2024-10-08 | Warnings | M012 |
| Rompe Pecho NT NT | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Efficient Laboratories Inc | 06faafaa-50a6-c16e-e063-6294a90a49cb | 2024-10-08 | Warnings | M012 |
| Mucus Relief Cough and Congestion DM | GUAIFENESIN AND DEXTROMETHORPHAN HBR | Bryant Ranch Prepack | 8c25285e-e2cd-4e10-af63-5dce8098b615 | 2024-10-08 | Warnings | M012 |
| Severe Throat Sore Drops | MENTHOL | Target Corporation Inc. | 949543d5-5043-ac06-e053-2995a90ab398 | 2024-10-07 | Warnings | M012 |
| Natural Herbal Cough Drops | COUGH DROPS | Target Corporation Inc. | a23ddfa9-19e0-99ee-e053-2a95a90a6856 | 2024-10-07 | Warnings | M012 |
| Cough Drops | SIMPLY MENTHOL COUGH DROPS | Perrigo Direct, Inc. | fb809c63-94f1-bb7a-e053-6294a90a0a39 | 2024-10-07 | Warnings | M012 |
| Cough Drops | SIMPLY CHERRY COUGH DROPS | Perrigo Direct, Inc. | fb808dc5-bf63-836c-e053-6294a90a80aa | 2024-10-07 | Warnings | M012 |
| Cough Drops | SIMPLY HONEY LEMON | Perrigo Direct Inc. | fb898616-d604-b4c3-e053-6294a90a23bf | 2024-10-07 | Warnings | M012 |
| Natural Herb Cough Drops | MENTHOL HERB | CVS Pharmacy | fcd16063-abca-49a0-e053-6294a90acb26 | 2024-10-07 | Warnings | M012 |
| Lemon Mint Herb Throat Drops | SUGAR FREE LEMON MINT HERB | CVS Pharmacy | fce6b5fa-846d-9911-e053-6294a90afc9b | 2024-10-07 | Warnings | M012 |
| Sugar Free Cough Drops | MENTHOL | CVS Pharmacy | fcd053e9-92ef-70ba-e053-6294a90aa4dd | 2024-10-07 | Warnings | M012 |
| Sugar Free Cough Drops | HONEY LEMON | CVS Pharmacy | f074a64d-dc01-1a37-e053-2995a90adc49 | 2024-10-07 | Warnings | M012 |
| Cough Drops | HONEY LEMON | CVS Pharmacy | f075010d-a07a-5e9d-e053-2995a90a3ca3 | 2024-10-07 | Warnings | M012 |
| Sugar Free Cough Drops | HONEY LEMON | CVS Pharmacy | fcd053e9-92ee-70ba-e053-6294a90aa4dd | 2024-10-07 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2640034 | {1 (acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution) / 1 (acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution) } Pack | GPCK | e5ef7b85-feee-44a7-bd0e-ed91352c7434 | 2 |
| 2640034 | 1 daytime (acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Granules for Oral Solution) Pack | PSN | e5ef7b85-feee-44a7-bd0e-ed91352c7434 | 2 |
| 1189316 | acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral Solution | PSN | e5ef7b85-feee-44a7-bd0e-ed91352c7434 | 2 |
| 1659960 | acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Granules for Oral Solution | PSN | e5ef7b85-feee-44a7-bd0e-ed91352c7434 | 2 |
| 1189316 | acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution | SCD | e5ef7b85-feee-44a7-bd0e-ed91352c7434 | 2 |
| 1659960 | acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution | SCD | e5ef7b85-feee-44a7-bd0e-ed91352c7434 | 2 |
| 2640034 | 1 daytime (acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG Granules for Oral Solution) Pack | SY | e5ef7b85-feee-44a7-bd0e-ed91352c7434 | 2 |
| 1189316 | acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Packet for Oral Solution | SY | e5ef7b85-feee-44a7-bd0e-ed91352c7434 | 2 |
| 1189316 | acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution | SY | e5ef7b85-feee-44a7-bd0e-ed91352c7434 | 2 |
| 1659960 | acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG Packet for Oral Solution | SY | e5ef7b85-feee-44a7-bd0e-ed91352c7434 | 2 |
| 1659960 | acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution | SY | e5ef7b85-feee-44a7-bd0e-ed91352c7434 | 2 |
| 1189316 | APAP 500 MG / Dextromethorphan Hydrobromide 20 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral Solution | SY | e5ef7b85-feee-44a7-bd0e-ed91352c7434 | 2 |
| 1659960 | APAP 650 MG / Diphenhydramine Hydrochloride 25 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral Solution | SY | e5ef7b85-feee-44a7-bd0e-ed91352c7434 | 2 |
| 1659960 | acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Granules for Oral Solution | PSN | 4daca846-8511-4303-9e6c-9469f7f260ba | 1 |
| 1659960 | acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution | SCD | 4daca846-8511-4303-9e6c-9469f7f260ba | 1 |
| 1659960 | acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG Packet for Oral Solution | SY | 4daca846-8511-4303-9e6c-9469f7f260ba | 1 |
| 1659960 | acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution | SY | 4daca846-8511-4303-9e6c-9469f7f260ba | 1 |
| 1659960 | APAP 650 MG / Diphenhydramine Hydrochloride 25 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral Solution | SY | 4daca846-8511-4303-9e6c-9469f7f260ba | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0067-6803-02 | 00067680302 | 6 PACKET in 1 CARTON (0067-6803-02) / 237 mL in 1 PACKET | 6 packet | 2023-01-20 | No | No | Current |