Theraflu ExpressMax
- Product NDC
- 0067-8129
- 11-digit product format
- 000678129
- Labeler code
- 0067
- Product ID
- 0067-8129_131827e6-0141-cf1d-e063-6294a90ae248
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Haleon US Holdings LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2015-07-15
- Substance
- ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 650; 25; 10 mg/30mL; mg/30mL; mg/30mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [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 ExpressMax
- Brand name suffix
- Nighttime Severe Cold and Cough
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 650 mg/30mL |
| DIPHENHYDRAMINE HYDROCHLORIDE | 25 mg/30mL |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/30mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| TC2D6JAD40 | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1298348 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| f5a66541-1b15-4dfe-91e0-d8d5f8fdc7fb | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0067-8129-08 | Theraflu ExpressMaxNighttime Severe Cold and Cough | 245.5 mL in 1 BOTTLE | SYRUP | 245.5 | 7 | |
| 0067-8129-08 | Theraflu ExpressMaxDaytime Nighttime Value Pack | 245.5 mL in 1 BOTTLE | SYRUP | 245.5 mL | 650 mg in 30mL | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0067-8129-08 | ML - Milliliter | 0067-8129 | d2541d5a-5905-40e7-bf8a-81fdf97222a8 | 1 | 2016-03-04 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0067-8129 | THERAFLU EXPRESSMAX NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [HALEON US HOLDINGS LLC] | 7 | Current NDC, Legacy NDC, 1 package rows | 20240308_f5a66541-1b15-4dfe-91e0-d8d5f8fdc7fb.zip |
| 0067-8129 | THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [HALEON US HOLDINGS LLC] | 5 | Current NDC, Legacy NDC | 20240411_9736ad4c-8c2e-421f-b023-f91b72d2828b.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 |
|---|---|---|---|---|---|---|
| OXYMETAZOLINE HYDROCHLORIDE | OXYMETAZOLINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION INC. | 2ee2b332-9b85-45a6-b242-3f0ebfbd08a6 | 2024-12-26 | Warnings | M012 |
| OXYMETAZOLINE HYDROCHLORIDE | OXYMETAZOLINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION INC | aebc7cf8-aaf7-4746-89f5-a64d0be1641e | 2024-12-26 | Warnings | M012 |
| Foster and Thrive Chest Congestion Relief | GUAIFENESIN | Strategic Sourcing Services LLC | a1661a66-5e8c-4144-9c82-cbbcc75fb222 | 2024-12-23 | Warnings | M012 |
| Geri Dryl | DIPHENHYDRAMINE HCL | GERI-CARE PHARMACEUTICALS, CORP | 34d36146-6827-4800-8483-c0edb8f4cc28 | 2024-12-23 | Warnings | M012 |
| Guaiasorb DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Geri-Care Pharmaceuticals, Corp | 6299e352-116e-43f2-b40f-c704a7bd5d61 | 2024-12-23 | Warnings | M012 |
| Equaline Chest Congestion Relief | GUAIFENESIN | United Natural Foods, Inc. dba UNFI | ad9fde8b-10cd-4778-917d-1ed6b67e5ab1 | 2024-12-23 | Warnings | M012 |
| Equaline Chest Congestion Relief DM DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | United Natural Foods, Inc. dba UNFI | a40f5893-eb96-4e0e-b965-d78293c48dc9 | 2024-12-23 | Warnings | M012 |
| Tukol X-Pecto Miel Multi Symptom Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Genomma Lab USA, Inc. | b9d32964-5bd7-44b0-be98-827d5310ed4f | 2024-12-20 | Warnings | M012 |
| Halls Honey Vanilla | MENTHOL | Mondelez Global LLC | 8e94a1b8-8915-4595-b097-8a0a319d54aa | 2024-12-20 | Warnings | M012 |
| Halls Sugar Free Mentho-Lyptus | MENTHOL | Mondelez Global LLC | 96046858-c57b-426e-8279-91b35e05bcdb | 2024-12-20 | Warnings | M012 |
| Vapor Inhaler levmetamfetamine nasal decongestant, Best Choice | LEVMETAMFETAMINE | Valu Merchandisers Company | 3f1c086c-bc22-4abb-9921-565a13f30c20 | 2024-12-20 | Warnings | M012 |
| Vapor Inhaler | LEVMETAMFETAMINE NASAL DECONGESTANT | Walgreens | 77924474-ccc7-497b-9168-91490bcfadfc | 2024-12-20 | Warnings | M012 |
| Levmetamfetamine | LEVMETAMFETAMINE | Meijer, Inc. | d11e916f-90a6-4099-bf83-75f2dfbd6266 | 2024-12-20 | Warnings | M012 |
| Vapor Inhaler levmetamfetamine nasal decongestant, DG health | LEVMETAMFETAMINE | Dolgencorp Inc. | 5dbc5a2d-feae-40d8-a8d4-1d6155a1bbd3 | 2024-12-20 | Warnings | M012 |
| Tukol Multi Symptom Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Genomma Lab USA, Inc. | aef2ad43-145d-4abc-bccc-2c5fdd6882f9 | 2024-12-20 | Warnings | M012 |
| Vapor Inhaler levmetamfetamine nasal decongestant, TopCare health | LEVMETAMFETAMINE | Topco Associates LLC | 8f995561-759a-4837-a82a-640417a6f889 | 2024-12-20 | Warnings | M012 |
| Childrens Cough | DEXTROMETHORPHAN HBR, GUAIFENESIN | Wal-Mart Stores, Inc. | 50a0eaa5-fa73-4d84-86fc-3546c85cf353 | 2024-12-20 | Warnings | M012 |
| Equate Childrens Multi symptom Cold Nighttime | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Wal-Mart Stores, Inc. | bfdaec98-24fe-47e1-ad32-dc2ddc4ce8ee | 2024-12-20 | Warnings | M012 |
| Vapor Inhaler | LEVMETAMFETAMINE NASAL DECONGESTANT | C.D.M.A., Inc. | 904b7e21-cce5-4b96-afc1-b36f532f98ac | 2024-12-20 | Warnings | M012 |
| Vapor Inhaler levmetamfetamine nasal decongestant, Equaline | LEVMETAMFETAMINE | Supervalu Inc. | 44f72f34-d0b8-421f-b240-86286de874cf | 2024-12-20 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1298348 | acetaminophen 325 MG / diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution | PSN | f5a66541-1b15-4dfe-91e0-d8d5f8fdc7fb | 7 |
| 1298348 | acetaminophen 21.7 MG/ML / diphenhydramine hydrochloride 0.833 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | f5a66541-1b15-4dfe-91e0-d8d5f8fdc7fb | 7 |
| 1298348 | acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | f5a66541-1b15-4dfe-91e0-d8d5f8fdc7fb | 7 |
| 1298348 | acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | f5a66541-1b15-4dfe-91e0-d8d5f8fdc7fb | 7 |
| 1298348 | APAP 21.7 MG/ML / Diphenhydramine Hydrochloride 0.833 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution | SY | f5a66541-1b15-4dfe-91e0-d8d5f8fdc7fb | 7 |
| 1803669 | {1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) / 1 (acetaminophen 21.7 MG/ML / diphenhydramine hydrochloride 0.833 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) } Pack | GPCK | 9736ad4c-8c2e-421f-b023-f91b72d2828b | 5 |
| 1803669 | 1 daytime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution) Pack | PSN | 9736ad4c-8c2e-421f-b023-f91b72d2828b | 5 |
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution | PSN | 9736ad4c-8c2e-421f-b023-f91b72d2828b | 5 |
| 1298348 | acetaminophen 325 MG / diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution | PSN | 9736ad4c-8c2e-421f-b023-f91b72d2828b | 5 |
| 1113705 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | 9736ad4c-8c2e-421f-b023-f91b72d2828b | 5 |
| 1298348 | acetaminophen 21.7 MG/ML / diphenhydramine hydrochloride 0.833 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | 9736ad4c-8c2e-421f-b023-f91b72d2828b | 5 |
| 1803669 | 1 daytime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution) Pack | SY | 9736ad4c-8c2e-421f-b023-f91b72d2828b | 5 |
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | 9736ad4c-8c2e-421f-b023-f91b72d2828b | 5 |
| 1298348 | acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | 9736ad4c-8c2e-421f-b023-f91b72d2828b | 5 |
| 1113705 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | 9736ad4c-8c2e-421f-b023-f91b72d2828b | 5 |
| 1298348 | acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | 9736ad4c-8c2e-421f-b023-f91b72d2828b | 5 |
| 1113705 | APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SY | 9736ad4c-8c2e-421f-b023-f91b72d2828b | 5 |
| 1298348 | APAP 21.7 MG/ML / Diphenhydramine Hydrochloride 0.833 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution | SY | 9736ad4c-8c2e-421f-b023-f91b72d2828b | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0067-8129-08 | 00067812908 | 245.5 mL in 1 BOTTLE (0067-8129-08) | 245.5 ml | 2015-07-15 | 0000-00-00 | No | No | Current |