Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough
- Product NDC
- 0067-8200
- 11-digit product format
- 000678200
- Labeler code
- 0067
- Product ID
- 0067-8200_15bf1214-572a-f6b6-e063-6394a90ab0cb
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Diphenhydramine HCl
- Dosage form
- KIT
- Labeler
- Haleon US Holdings LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2016-01-01
- 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 Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough
- Listing expiration
- 2026-12-31
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| b06b64c5-dbb4-4ef5-af18-3d7d4979c02f | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e4e263da-1c53-440f-bb80-b7a575843b5a | Product name | 1 | 20260313 |
| d2168cac-a261-415a-9c78-3522859fa720 | Product name | 3 | 20251124 |
| 05a8cdd1-eeb8-409e-b938-0778225eca7d | Product name | 4 | 20250221 |
| e5b5c132-b15d-435b-9faa-2f74e5cadcf9 | Product name | 8 | 20250220 |
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| f489e8f3-5c9e-4818-b539-a73587edcfc7 | Product name | 2 | 20240229 |
| 0f7ae452-206d-4fc4-868d-56fc47074084 | Product name | 1 | 20231011 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0067-8200-01 | 2024-01-30 | C162847 | 48780-1 | 1030e365-54e7-111a-e063-dadaa90a10e2 | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0067-6426-01 | Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough | 237 mL in 1 PACKET | POWDER, FOR SOLUTION | 4266 mL | 500 mg in 237mL | 8 |
| 0067-6426-06 | Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough | 6 in 1 CARTON | POWDER, FOR SOLUTION | 500 mg in 237mL | 8 | |
| 0067-7918-01 | Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough | 237 mL in 1 PACKET | POWDER, FOR SOLUTION | 1422 mL | 650 mg in 237mL | 8 |
| 0067-7918-06 | Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough | 6 in 1 CARTON | POWDER, FOR SOLUTION | 650 mg in 237mL | 8 | |
| 0067-8200-01 | Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough | 1 in 1 PACKAGE, COMBINATION | KIT | 1 | 8 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0067-8200 | THERAFLU MULTI-SYMPTOM SEVERE COLD AND THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL) KIT [HALEON US HOLDINGS LLC] | 8 | Current NDC, Legacy NDC, 5 package rows | 20240411_b06b64c5-dbb4-4ef5-af18-3d7d4979c02f.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 |
|---|---|---|---|---|---|---|
| Mucinex Childrens FreeFrom Multi-Symptom Cold, Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 14c56f3d-67fd-45ef-a16b-f27604722883 | 2026-05-12 | Warnings | M012 |
| ALKA SELTZER COLD Cold Mucus and Congestion Maximum Strength Day Night Fast Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare, LLC. | 51a4195b-8776-964c-e063-6294a90aa075 | 2026-05-12 | Warnings | M012 |
| Mucinex Fast-Max Cold and Flu and Mucinex Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 3ba3548e-85e7-b4a6-e063-6394a90af84d | 2026-05-12 | Warnings | M012 |
| Maximum Strength Mucinex Fast-Max Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | fe7eeb71-e219-4c84-ac06-98c3a40b14dc | 2026-05-12 | Warnings | M012 |
| Maximum Strength Mucinex Fast-Max Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 6f8241d7-0f30-40b3-926b-861c57079f1d | 2026-05-12 | Warnings | M012 |
| Alka Seltzer COLD Cold Mucus Congestion Maximum Strength Fast Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 51a45db8-2bee-6fd0-e063-6394a90ab587 | 2026-05-12 | Warnings | M012 |
| Maximum Strength Mucinex Fast-Max Day Cold and Flu and Night Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 19da539e-7b57-41d7-aad5-fc89a6705e20 | 2026-05-12 | Warnings | M012 |
| Maximum Strength Mucinex Fast-Max Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 182222b5-a852-4dbe-b05f-a41d89806021 | 2026-05-12 | Warnings | M012 |
| Maximum Strength Mucinex Fast-Max Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 8a790eeb-7d7d-4a94-9103-6ed09c04d596 | 2026-05-12 | Warnings | M012 |
| Mucinex Fast-Max Day Cold and Flu and Mucinex Nightshift Night Severe Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | dbdafbb4-f3c9-4042-b867-db4d06dc3d61 | 2026-05-12 | Warnings | M012 |
| Maximum Strength Mucinex Sinus-Max Pressure, Pain and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | d03ef2fd-1a08-42c0-b69d-fd4e4285ccd3 | 2026-05-12 | Warnings | M012 |
| Maximum Strength Mucinex Fast-Max Cold and Flu and Mucinex NightShift Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 29571047-4c4b-44ca-8726-57c28308e8cf | 2026-05-12 | Warnings | M012 |
| Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain and Mucinex Nightshift Sinus | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 75c6b92f-219f-4740-bb72-c02a927a21ff | 2026-05-12 | Warnings | M012 |
| Mucinex Sinus-Max Day Pressure, Pain and Cough and Mucinex Nightshift Night Sinus Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | c746953f-4b7d-4e2a-9b85-96bd6901f517 | 2026-05-12 | Warnings | M012 |
| Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | cea08797-1d53-4434-be1a-144f2ded5f9d | 2026-05-12 | Warnings | M012 |
| Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 2ef9d5de-e99e-4398-bf97-c7bef94498fa | 2026-05-12 | Warnings | M012 |
| Mucinex Fast-Max Day Severe Congestion and Cough and Mucinex Nightshift Night Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | a401eb92-60b6-427d-a677-29371a3150be | 2026-05-12 | Warnings | M012 |
| Mucinex Fast-Max Cold, Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | c902b4fc-c71c-4ef2-b5cb-6c2bd019acbc | 2026-05-12 | Warnings | M012 |
| Mucinex Fast-Max Severe Congestion and Cough | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 3ff4c4ea-7628-4d2b-a6e9-d994c25baef4 | 2026-05-12 | Warnings | M012 |
| Mucinex Fast-Max Cold, Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | d7c18e95-8d7b-4550-9a20-fc704a114adb | 2026-05-12 | 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 | b06b64c5-dbb4-4ef5-af18-3d7d4979c02f | 8 |
| 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 | b06b64c5-dbb4-4ef5-af18-3d7d4979c02f | 8 |
| 1189316 | acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral Solution | PSN | b06b64c5-dbb4-4ef5-af18-3d7d4979c02f | 8 |
| 1659960 | acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Granules for Oral Solution | PSN | b06b64c5-dbb4-4ef5-af18-3d7d4979c02f | 8 |
| 1189316 | acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution | SCD | b06b64c5-dbb4-4ef5-af18-3d7d4979c02f | 8 |
| 1659960 | acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution | SCD | b06b64c5-dbb4-4ef5-af18-3d7d4979c02f | 8 |
| 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 | b06b64c5-dbb4-4ef5-af18-3d7d4979c02f | 8 |
| 1189316 | acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Packet for Oral Solution | SY | b06b64c5-dbb4-4ef5-af18-3d7d4979c02f | 8 |
| 1189316 | acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution | SY | b06b64c5-dbb4-4ef5-af18-3d7d4979c02f | 8 |
| 1659960 | acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG Packet for Oral Solution | SY | b06b64c5-dbb4-4ef5-af18-3d7d4979c02f | 8 |
| 1659960 | acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution | SY | b06b64c5-dbb4-4ef5-af18-3d7d4979c02f | 8 |
| 1189316 | APAP 500 MG / Dextromethorphan Hydrobromide 20 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral Solution | SY | b06b64c5-dbb4-4ef5-af18-3d7d4979c02f | 8 |
| 1659960 | APAP 650 MG / Diphenhydramine Hydrochloride 25 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral Solution | SY | b06b64c5-dbb4-4ef5-af18-3d7d4979c02f | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0067-6426-01 | 00067642601 | 237 mL in 1 PACKET | 237 ml | Historical | ||||
| 0067-6426-06 | 00067642606 | 6 in 1 CARTON | Historical | |||||
| 0067-7918-01 | 00067791801 | 237 mL in 1 PACKET | 237 ml | Historical | ||||
| 0067-7918-06 | 00067791806 | 6 in 1 CARTON | Historical | |||||
| 0067-8200-01 | 00067820001 | 1 KIT in 1 PACKAGE, COMBINATION (0067-8200-01) * 6 PACKET in 1 CARTON (0067-6426-06) / 237 mL in 1 PACKET (0067-6426-01) * 6 PACKET in 1 CARTON (0067-7918-06) / 237 mL in 1 PACKET (0067-7918-01) | 1 kit | 2019-09-01 | 0000-00-00 | No | No | Current |