Theraflu Severe Cold Relief Nighttime
- Product NDC
- 0067-0101
- 11-digit product format
- 000670101
- Labeler code
- 0067
- Product ID
- 0067-0101_132abfab-e435-15af-e063-6294a90a6901
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN, DIPHENHYDRAMINE HCl
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- Haleon US Holdings LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-12-01
- Substance
- ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
- Active strength
- 650; 25 mg/1; mg/1
- 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
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 Severe Cold Relief Nighttime
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 650 mg/1 |
| DIPHENHYDRAMINE HYDROCHLORIDE | 25 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| TC2D6JAD40 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2670677 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 14e38ef0-a5e7-4df7-824f-f27bef664d25 | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0067-0101-06 | 2024-01-30 | C162847 | 48780-1 | 1030e365-47b8-111a-e063-dadaa90a10e2 | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0067-0101-06 | Theraflu Severe Cold Relief Nighttime | 1 in 1 PACKET | POWDER, FOR SOLUTION | 1 | 2 | |
| 0067-0101-06 | Theraflu Severe Cold Relief Nighttime | 6 in 1 CARTON | POWDER, FOR SOLUTION | 6 | 2 | |
| 0067-0101-06 | TherafluSevere Cold Relief Combo Pack | 1 in 1 PACKET | POWDER, FOR SOLUTION | 1 | 25 mg | 1 |
| 0067-0101-06 | TherafluSevere Cold Relief Combo Pack | 6 in 1 CARTON | POWDER, FOR SOLUTION | 650 mg | 1 | |
| 0067-0101-06 | TherafluSevere Cold Relief Combo Pack | 1 in 1 PACKET | POWDER, FOR SOLUTION | 1 | 650 mg | 1 |
| 0067-0101-06 | TherafluSevere Cold Relief Combo Pack | 6 in 1 CARTON | POWDER, FOR SOLUTION | 650 mg | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0067-0101 | THERAFLU SEVERE COLD RELIEF NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) POWDER, FOR SOLUTION [HALEON US HOLDINGS LLC] | 2 | Current NDC, 2 package rows | 20240310_14e38ef0-a5e7-4df7-824f-f27bef664d25.zip |
| 0067-0101 | THERAFLU SEVERE COLD RELIEF COMBO PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL) KIT [HALEON US HOLDINGS LLC] | 1 | Current NDC | 20240704_682c5a4b-5ded-4276-903f-1ef1141ae518.zip |
| 0067-0101 | THERAFLU SEVERE COLD RELIEF COMBO PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL) KIT [HALEON US HOLDINGS LLC] | 1 | Current NDC | 20240415_f147d82e-4429-4c7b-bd2b-e21a09f21c92.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 |
|---|---|---|---|---|---|---|
| Robitussin Medi-Soothers | DEXTROMETHORPHAN HYDROBROMIDE, MENTHOL | Haleon US Holdings LLC | 4c3d57e3-e40b-41ca-b44b-5f4c5f4dbae5 | 2024-04-06 | Warnings | M012 |
| DEXTROMETHORPHAN HBR, GUAIFENESIN | DEXTROMETHORPHAN HBR, GUAIFENESIN | OPMX LLC | 9a16e7f3-78aa-0b01-e053-2a95a90ab19c | 2024-04-05 | Warnings | M012 |
| Theraflu Severe Cold Relief Daytime Honey Ginger | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | Haleon US Holdings LLC | 44404c6a-8031-4f4b-a48e-3739a11a0d2c | 2024-04-05 | Warnings | M012 |
| Activcin | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | OPMX LLC. | e06a4d72-cc8d-fd9d-e053-2995a90a7a76 | 2024-04-05 | Warnings | M012 |
| Coldtac Plus Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | OPMX LLC. | ff5ce5c6-a03f-2ad3-e053-6394a90a99f6 | 2024-04-05 | Warnings | M012 |
| Desresfriol-DX Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | OPMX LLC. | ff5e0e0f-bfd2-b02b-e053-6394a90afe8a | 2024-04-05 | Warnings | M012 |
| Leader Nasal Decongestant | OXYMETAZOLINE HYDROCHLORIDE | Cardinal Health 110,Inc | 98bf8e84-b555-4b5a-90a0-7837a5560289 | 2024-04-03 | Warnings | M012 |
| DAYTIME COLD AND FLU RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Advanced Rx LLC | 38299cf3-e884-4676-8cc4-6dd64e7d023c | 2024-03-30 | Warnings | M012 |
| NIGHTTIME COLD AND FLU RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | Advanced Rx LLC | d1542362-19c5-4470-89e8-87d26e2ca8ed | 2024-03-30 | Warnings | M012 |
| ANTIGRIP Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Pharmadel LLC | 12de30fd-95b6-f16d-e063-6294a90aeba2 | 2024-03-27 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Family Dollar (FAMILY WELLNESS) | 0044c53c-11dd-41a9-a5d9-622dd8b1c144 | 2024-03-27 | Warnings | M012 |
| Codeine-Guaifenesin | CODEINE PHOSPHATE AND GUAIFENESIN | Bryant Ranch Prepack | 9812056b-736e-40c5-ae60-21dd9221397c | 2024-03-22 | Warnings | M012 |
| Tussin CF | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Best Choice (Valu Merchandisers Company) | 1b7b5811-722e-4c4a-844d-c05fa5cfb2e5 | 2024-03-21 | Warnings | M012 |
| Daytime and Nighttime Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCL / ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Walgreens | da2a77c3-7d0f-157b-e053-2995a90a951a | 2024-03-19 | Warnings | M012 |
| Robitussin Medi-Soothers | DEXTROMETHORPHAN HYDROBROMIDE, MENTHOL | Haleon US Holdings LLC | 6bec225e-a203-4866-b0db-b76f73a6ae25 | 2024-03-19 | Warnings | M012 |
| Cold and Flu Relief Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 06d47104-a8ca-48cc-b27e-08c9d018c37b | 2024-03-19 | Warnings | M012 |
| Cold and Flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | b80dae7f-ed2d-4a9e-bef9-f1ed8add0174 | 2024-03-19 | Warnings | M012 |
| Daytime Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | WALGREENS | c945c35e-de0d-0fd6-e053-2995a90a1fbf | 2024-03-19 | Warnings | M012 |
| Daytime Nighttime Sinus Relief Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL/ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE,PHENYLEPHRINE HCL | Walgreens | da046b01-707c-326a-e053-2995a90a0927 | 2024-03-19 | Warnings | M012 |
| DAYTIME NIGHTTIME SEVERE COLD AND FLU Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCL / ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Walgreens | da2b0276-9ab0-38e6-e053-2a95a90a54d8 | 2024-03-19 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2670677 | acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG Powder for Oral Solution | PSN | 14e38ef0-a5e7-4df7-824f-f27bef664d25 | 2 |
| 2670677 | acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG Powder for Oral Solution | SCD | 14e38ef0-a5e7-4df7-824f-f27bef664d25 | 2 |
| 2670677 | acetaminophen 650 MG / diphenhydramine HCl 25 MG Granules for Oral Solution | SY | 14e38ef0-a5e7-4df7-824f-f27bef664d25 | 2 |
| 2670677 | acetaminophen 650 MG / diphenhydramine HCl 25 MG Packet for Oral Solution | SY | 14e38ef0-a5e7-4df7-824f-f27bef664d25 | 2 |
| 2670677 | APAP 650 MG / diphenhydramine hydrochloride 25 MG Powder for Oral Solution | SY | 14e38ef0-a5e7-4df7-824f-f27bef664d25 | 2 |
| 2679426 | {1 (acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Granules for Oral Solution) / 1 (acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG Granules for Oral Solution) } Pack | GPCK | 682c5a4b-5ded-4276-903f-1ef1141ae518 | 1 |
| 2679426 | {1 (acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Granules for Oral Solution) / 1 (acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG Granules for Oral Solution) } Pack | GPCK | f147d82e-4429-4c7b-bd2b-e21a09f21c92 | 1 |
| 2679426 | 1 daytime (acetaminophen 500 MG / dextromethorphan HBr 20 MG Granules for Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG Granules for Oral Solution) Pack | PSN | f147d82e-4429-4c7b-bd2b-e21a09f21c92 | 1 |
| 2679426 | 1 daytime (acetaminophen 500 MG / dextromethorphan HBr 20 MG Granules for Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG Granules for Oral Solution) Pack | PSN | 682c5a4b-5ded-4276-903f-1ef1141ae518 | 1 |
| 2679420 | acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Granules for Oral Solution | PSN | 682c5a4b-5ded-4276-903f-1ef1141ae518 | 1 |
| 2679420 | acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Granules for Oral Solution | PSN | f147d82e-4429-4c7b-bd2b-e21a09f21c92 | 1 |
| 2670598 | acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Powder for Oral Solution | PSN | 682c5a4b-5ded-4276-903f-1ef1141ae518 | 1 |
| 2670598 | acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Powder for Oral Solution | PSN | f147d82e-4429-4c7b-bd2b-e21a09f21c92 | 1 |
| 2670677 | acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG Powder for Oral Solution | PSN | 6ee1cc52-2d7e-4b53-a0e6-563e623bcb51 | 1 |
| 2670677 | acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG Powder for Oral Solution | PSN | 682c5a4b-5ded-4276-903f-1ef1141ae518 | 1 |
| 2670677 | acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG Powder for Oral Solution | PSN | f147d82e-4429-4c7b-bd2b-e21a09f21c92 | 1 |
| 2679425 | acetaminophen 650 MG / diphenhydrAMINE hydrochloride 25 MG Granules for Oral Solution | PSN | f147d82e-4429-4c7b-bd2b-e21a09f21c92 | 1 |
| 2679425 | acetaminophen 650 MG / diphenhydrAMINE hydrochloride 25 MG Granules for Oral Solution | PSN | 682c5a4b-5ded-4276-903f-1ef1141ae518 | 1 |
| 2679420 | acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Granules for Oral Solution | SCD | f147d82e-4429-4c7b-bd2b-e21a09f21c92 | 1 |
| 2679420 | acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Granules for Oral Solution | SCD | 682c5a4b-5ded-4276-903f-1ef1141ae518 | 1 |
| 2670598 | acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Powder for Oral Solution | SCD | 682c5a4b-5ded-4276-903f-1ef1141ae518 | 1 |
| 2670598 | acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Powder for Oral Solution | SCD | f147d82e-4429-4c7b-bd2b-e21a09f21c92 | 1 |
| 2679425 | acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG Granules for Oral Solution | SCD | f147d82e-4429-4c7b-bd2b-e21a09f21c92 | 1 |
| 2679425 | acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG Granules for Oral Solution | SCD | 682c5a4b-5ded-4276-903f-1ef1141ae518 | 1 |
| 2670677 | acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG Powder for Oral Solution | SCD | 6ee1cc52-2d7e-4b53-a0e6-563e623bcb51 | 1 |
| 2670677 | acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG Powder for Oral Solution | SCD | f147d82e-4429-4c7b-bd2b-e21a09f21c92 | 1 |
| 2670677 | acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG Powder for Oral Solution | SCD | 682c5a4b-5ded-4276-903f-1ef1141ae518 | 1 |
| 2679426 | {1 (acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Powder for Oral Solution) / 1 (acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG Powder for Oral Solution) } Pack | SY | f147d82e-4429-4c7b-bd2b-e21a09f21c92 | 1 |
| 2679426 | {1 (acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Powder for Oral Solution) / 1 (acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG Powder for Oral Solution) } Pack | SY | 682c5a4b-5ded-4276-903f-1ef1141ae518 | 1 |
| 2679426 | 1 daytime (acetaminophen 500 MG / dextromethorphan HBr 20 MG Granules for Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydramine HCl 25 MG Granules for Oral Solution) Pack | SY | f147d82e-4429-4c7b-bd2b-e21a09f21c92 | 1 |
| 2679426 | 1 daytime (acetaminophen 500 MG / dextromethorphan HBr 20 MG Granules for Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydramine HCl 25 MG Granules for Oral Solution) Pack | SY | 682c5a4b-5ded-4276-903f-1ef1141ae518 | 1 |
| 2670677 | acetaminophen 650 MG / diphenhydramine HCl 25 MG Granules for Oral Solution | SY | 6ee1cc52-2d7e-4b53-a0e6-563e623bcb51 | 1 |
| 2670677 | acetaminophen 650 MG / diphenhydramine HCl 25 MG Granules for Oral Solution | SY | f147d82e-4429-4c7b-bd2b-e21a09f21c92 | 1 |
| 2670677 | acetaminophen 650 MG / diphenhydramine HCl 25 MG Granules for Oral Solution | SY | 682c5a4b-5ded-4276-903f-1ef1141ae518 | 1 |
| 2670677 | acetaminophen 650 MG / diphenhydramine HCl 25 MG Packet for Oral Solution | SY | f147d82e-4429-4c7b-bd2b-e21a09f21c92 | 1 |
| 2670677 | acetaminophen 650 MG / diphenhydramine HCl 25 MG Packet for Oral Solution | SY | 682c5a4b-5ded-4276-903f-1ef1141ae518 | 1 |
| 2670677 | acetaminophen 650 MG / diphenhydramine HCl 25 MG Packet for Oral Solution | SY | 6ee1cc52-2d7e-4b53-a0e6-563e623bcb51 | 1 |
| 2679420 | APAP 500 MG / dextromethorphan hydrobromide 20 MG Granules for Oral Solution | SY | 682c5a4b-5ded-4276-903f-1ef1141ae518 | 1 |
| 2679420 | APAP 500 MG / dextromethorphan hydrobromide 20 MG Granules for Oral Solution | SY | f147d82e-4429-4c7b-bd2b-e21a09f21c92 | 1 |
| 2670598 | APAP 500 MG / dextromethorphan hydrobromide 20 MG Powder for Oral Solution | SY | 682c5a4b-5ded-4276-903f-1ef1141ae518 | 1 |
| 2670598 | APAP 500 MG / dextromethorphan hydrobromide 20 MG Powder for Oral Solution | SY | f147d82e-4429-4c7b-bd2b-e21a09f21c92 | 1 |
| 2679425 | APAP 650 MG / diphenhydramine hydrochloride 25 MG Granules for Oral Solution | SY | 682c5a4b-5ded-4276-903f-1ef1141ae518 | 1 |
| 2679425 | APAP 650 MG / diphenhydramine hydrochloride 25 MG Granules for Oral Solution | SY | f147d82e-4429-4c7b-bd2b-e21a09f21c92 | 1 |
| 2670677 | APAP 650 MG / diphenhydramine hydrochloride 25 MG Powder for Oral Solution | SY | 6ee1cc52-2d7e-4b53-a0e6-563e623bcb51 | 1 |
| 2670677 | APAP 650 MG / diphenhydramine hydrochloride 25 MG Powder for Oral Solution | SY | 682c5a4b-5ded-4276-903f-1ef1141ae518 | 1 |
| 2670677 | APAP 650 MG / diphenhydramine hydrochloride 25 MG Powder for Oral Solution | SY | f147d82e-4429-4c7b-bd2b-e21a09f21c92 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0067-0101-06 | 00067010106 | 6 PACKET in 1 CARTON (0067-0101-06) / 1 POWDER, FOR SOLUTION in 1 PACKET | 6 packet | 2023-12-01 | No | No | Current |