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 |
|---|---|---|---|---|---|---|
| Severe Cold | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | cf2dd1fb-1d5b-428e-8c9a-a46dbd7cb645 | 2025-05-07 | Warnings | M012 |
| Theraflu Severe Cold Relief Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | Haleon US Holdings LLC | 2b962d87-6ff5-4c0f-8504-e5b61c940612 | 2025-05-05 | Warnings | M012 |
| Cough and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE LIQUID | CVS | 2d13564a-e8d1-c357-e063-6394a90ad90e | 2025-05-02 | Warnings | M012 |
| SUDAFED OM Sinus Severe No Drip Nasal Mist with Cooling Menthol | OXYMETAZOLINE HYDROCHLORIDE | Kenvue Brands LLC | 33fe0e49-3de5-8afd-e063-6294a90a0ad5 | 2025-05-02 | Warnings | M012 |
| Daytime and Nighttime High Blood Pressure Cold and Flu Liquid | ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | CVS Pharmacy, Inc. | 2d13964a-8cc4-f3dc-e063-6394a90aa105 | 2025-05-02 | Warnings | M012 |
| DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML | DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML | AARNA USA INC. | 32c26835-f54e-d7e5-e063-6294a90ae1c0 | 2025-04-30 | Warnings | M012 |
| SUDAFED OM Sinus Severe No Drip Nasal Mist | OXYMETAZOLINE HYDROCHLORIDE | Kenvue Brands LLC | 33e6239b-364a-0e62-e063-6294a90a5047 | 2025-04-29 | Warnings | M012 |
| Childrens Allergy Relief | DIPHENHYDRAMINE HCL | CVS Pharmacy | 8296049c-72fc-4200-9d45-c8e377314cf2 | 2025-04-29 | Warnings | M012 |
| NIGHTTIME COLD AND FLU RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE | Aurohealth LLC | 70e1bd25-c32e-491f-b383-91d6f74957a0 | 2025-04-28 | Warnings | M012 |
| Childrens Allergy Relief Dye Free | DIPHENHYDRAMINE HCL | CVS Pharmacy | 70914691-220c-4fce-9ee1-61a51e8864bc | 2025-04-26 | Warnings | M012 |
| Pseudoephedrine Hydrochloride | PSEUDOEPHEDRINE HYDROCHLORIDE | A-S Medication Solutions | 810ce630-41be-4e15-b64a-d70f63abaf62 | 2025-04-24 | Warnings | M012 |
| nasal | OXYMETAZOLINE HYDROCHLORIDE | H E B | 5f945975-224f-43eb-b129-a61e3b25c4bb | 2025-04-22 | Warnings | M012 |
| Walgreens Severe Honey Lemon Throat Drops | MENTHOL | Walgreens | 334a9348-2a44-5c94-e063-6394a90ae956 | 2025-04-21 | Warnings | M012 |
| meijer Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Meijer, Inc. | 1bd85bc3-e600-583d-e063-6294a90a7be1 | 2025-04-18 | Warnings | M012 |
| Daytime Nighttime Ultra Concentrated | DAYTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | KROGER COMPANY | 2be4a37b-44e1-8a8e-e063-6394a90a26a9 | 2025-04-17 | Warnings | M012 |
| good neighbor pharmacy childrens cold and cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | Amerisource Bergen | cde0fd43-771f-4528-bad2-5727efec5250 | 2025-04-17 | Warnings | M012 |
| MUCUS RELIEF | GUAIFENESIN 400 MG | Pioneer Life Sciences, LLC | 729ab412-f30b-4ad1-9d8f-1a5e1c48b118 | 2025-04-16 | Warnings | M012 |
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 9382c976-3067-4923-a38f-101d1c481e97 | 2025-04-11 | Warnings | M012 |
| Daytime Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HCL LIQUID FILLED CAPSULES | Walmart Inc. | 263d31c8-bdc2-a289-e063-6394a90a4aaa | 2025-04-10 | Warnings | M012 |
| CVS Wild Cherry Throat Drop | PECTIN | CVS | 31f4b641-e9c0-786e-e063-6394a90aa253 | 2025-04-04 | 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 |