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 |
|---|---|---|---|---|---|---|
| Allergy Childrens Allergy | DIPHENHYDRAMINE HYDROCHLORIDE | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 047102c4-3d03-4b2d-961d-0ac75980147b | 2026-05-06 | Warnings | M012 |
| GOOD SENSE COMBO PACK DAYTIME AND NIGHTTIME | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | L. Perrigo Company | d25f2649-4f8a-4339-8443-faa0b98bdd70 | 2026-05-06 | Warnings | M012 |
| Allergy Relief 4 Hour | CHLORPHENIRAMINE MALEATE | WinCo Foods, LLC | 27e911e1-6d22-4a50-8413-1809c8973cbd | 2026-05-06 | Warnings | M012 |
| ALKA SELTZER COLD Cold Cough Maximum Strength Fast Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 51173330-d537-fb9c-e063-6394a90ae342 | 2026-05-05 | Warnings | M012 |
| Equate daytime severe vaporice cold and flu nighttime severe vapor ice cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | Wal-Mart Stores Inc | 08e74a8d-8e8d-4cda-9adc-ea2ff4068353 | 2026-05-05 | Warnings | M012 |
| GOODSENSE COMBO PACK DAYTIME AND NIGHTTIME | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL | L. Perrigo Company | e42f9e0d-f990-4c33-af43-75acf5d77638 | 2026-05-05 | Warnings | M012 |
| Rugby Mucus and Chest Congestion 541 | GUAIFENESIN | Rugby Laboratories | 76472912-b66f-4bb4-937a-4a589683a78c | 2026-05-04 | Warnings | M012 |
| Sinus Congestion and Pain Daytime Non-Drowsy | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE | H E B | e9dd2d7b-0a19-4a42-b51e-b9914f02406e | 2026-05-04 | Warnings | M012 |
| Sanatos Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Pharmadel LLC | 3dd3ed85-0c0a-8390-e063-6294a90a668e | 2026-05-04 | Warnings | M012 |
| Good Sense Daytime non drowsy cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | L. Perrigo Company | 0122cd34-5817-4af5-a51a-8d176dee0a30 | 2026-05-04 | Warnings | M012 |
| COLD AND FLU RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Safeway | d810a6a9-6112-4e9d-a396-36084b7e110e | 2026-05-04 | Warnings | M012 |
| Benadryl Allergy Ultratab | DIPHENHYDRAMINE HYDROCHLORIDE | Savings Distributors LLC | 8d59d121-62a8-c43b-e053-2a95a90a5847 | 2026-05-01 | Warnings | M012 |
| Tylenol Cold Plus Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Savings Distributors LLC | 8e87f8de-f83e-0f8d-e053-2a95a90a8d6a | 2026-05-01 | Warnings | M012 |
| Tylenol Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Savings Distributors LLC | 8eecb3f0-eb5e-e847-e053-2995a90a86bd | 2026-05-01 | Warnings | M012 |
| Sinus Pressure and Congestion Relief PE Maximum Strength | PHENYLEPHRINE HCL | Rite Aid Corporation | fccea3c5-42af-4939-82bc-d9409b75f91f | 2026-05-01 | Warnings | M012 |
| Night Time Cold and Flu original | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Harris Teeter, LLC | cfaf4b3d-fab4-424d-adbe-aaedca58912d | 2026-04-30 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Harris Teeter, LLC | 21e7d323-5b78-43aa-b0fc-34c2a864ab9a | 2026-04-30 | Warnings | M012 |
| daytime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | H E B | ec0b5f4b-b58c-445f-acf1-c7ce301bba64 | 2026-04-30 | Warnings | M012 |
| Mucus Relief DM Max Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN | Harris Teeter, LLC | 098428ae-e87d-4c29-8f02-1590530da58e | 2026-04-29 | Warnings | M012 |
| Panadol Cold and Flu Day | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | Haleon US Holdings LLC | 341761b9-f0be-f816-e063-6394a90a5e63 | 2026-04-29 | 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 |