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 |
|---|---|---|---|---|---|---|
| tussin severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | H E B | 7cc2c136-d1b7-4658-99bb-73bb1d140261 | 2024-11-04 | Warnings | M012 |
| dg health tussin | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Dolgencorp Inc | a5d0ee70-d528-4a53-bf01-7bb13b364ed0 | 2024-11-04 | Warnings | M012 |
| basic care tussin cf severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Amazon.com Services LLC | bba9a17d-eb87-46f3-acee-c9dd34e5bfd4 | 2024-11-04 | Warnings | M012 |
| topcare tussin cf max | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Topco Associates LLC | b553b7e6-933b-49e3-97d3-22a4643a04b9 | 2024-11-04 | Warnings | M012 |
| dg health nasal original | OXYMETAZOLINE HYDROCHLORIDE | Dolgencorp, LLC | fb209752-705a-4bb0-9298-8b70357f3911 | 2024-11-02 | Warnings | M012 |
| nasal | OXYMETAZOLINE HYDROCHLORIDE | H E B | 3c301993-642a-487c-96a2-ebc4ef90dc88 | 2024-11-02 | Warnings | M012 |
| basic care nighttime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Amazon.com Services LLC | 1341744c-43c3-462b-b93c-1e46476fd935 | 2024-11-01 | Warnings | M012 |
| Nighttime Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | CVS Pharmacy | 43784616-1afd-4ff7-8fee-6ac389f616a2 | 2024-11-01 | Warnings | M012 |
| topcare nite time cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Topco Associates LLC | 28ef87e8-29e5-444d-b1f7-5c38a7f758d3 | 2024-11-01 | Warnings | M012 |
| Good Sense Severe NightTime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | L. Perrigo Company | 0e3c36c9-d45b-41b9-891d-a42d854295f9 | 2024-11-01 | Warnings | M012 |
| severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Walgreen Company | 7dc3941a-e5f8-4caa-bae5-6a0d075295cb | 2024-11-01 | Warnings | M012 |
| DoloMax Cold Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | BENARD INDUSTRIES INC | 520aee75-8b9a-4dcc-8970-75e122640e91 | 2024-10-31 | Warnings | M012 |
| Good Sense Nasal | OXYMETAZOLINE HYDROCHLORIDE | A-S Medication Solutions | b6fbc0ba-7e88-4ab9-b0fa-1e1e8f9132fe | 2024-10-31 | Warnings | M012 |
| CareOne Nighttime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | American Sales Company | 819d5c82-0240-4013-9904-c335bd65d03e | 2024-10-30 | Warnings | M012 |
| Signature Care Nighttime Severe Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Safeway | 9a0ad5d5-8fd9-468d-be2c-87c14d08b934 | 2024-10-30 | Warnings | M012 |
| Good Sense Severe NightTime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | L. Perrigo Company | f2b77bc3-ba1e-4c3f-bbbd-fa93b2c37dd2 | 2024-10-30 | Warnings | M012 |
| dg health cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Dolgencorp, LLC | 81f3ac36-9bae-4f42-92a0-8a2e4bbd0984 | 2024-10-30 | Warnings | M012 |
| severe cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Rite Aid Corporation | 9a71e8eb-4195-4694-bf3e-44f691ff2cef | 2024-10-30 | Warnings | M012 |
| nighttime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | H E B | fe4a95d2-6fb3-43fe-baec-6f22d1965323 | 2024-10-30 | Warnings | M012 |
| NightTime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Kroger Company | 2c9ef0d7-3d5b-494a-8f06-9dd42110d78a | 2024-10-30 | 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 |