Maximum strength Max Cold and Sinus
- Product NDC
- 76281-515
- 11-digit product format
- 762810515
- Labeler code
- 76281
- Product ID
- 76281-515_ca73e55a-9cf6-4629-9e2d-2c2c9f328ad2
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCl
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- AptaPharma Inc.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-01-30
- Substance
- ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 650; 400; 10 mg/20mL; mg/20mL; mg/20mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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
- Maximum strength Max Cold and Sinus
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 650 mg/20mL |
| GUAIFENESIN | 400 mg/20mL |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/20mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 495W7451VQ | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1116568 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 263dae13-5f92-4505-8bcc-e903d05b9a0c | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76281-515-25 | Maximum strength Max Cold and Sinus | 177 mL in 1 BOTTLE | LIQUID | 177 | 1 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Biofreeze Colorless | MENTHOL | A-S Medication Solutions | cc1cba14-da40-4d7d-b522-b5c648798e96 | 2024-11-11 | Warnings | M012 |
| foster and thrive nighttime severe cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Strategic Sourcing Services LLC | 298b7754-d0d8-496d-9949-4c346cb11e34 | 2024-11-11 | Warnings | M012 |
| leader tussin dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Cardinal Health 110, LLC. dba Leader | b418c10c-528b-4395-944e-af959b639ec2 | 2024-11-10 | Warnings | M012 |
| equaline adult tussin | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | United Natural Foods, Inc. dba UNFI | f7c753f8-4b12-4797-a599-736d597bc1bc | 2024-11-10 | Warnings | M012 |
| foster and thrive adult tussin dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Strategic Sourcing Services LLC | f8933226-fbc9-44e3-a90f-4e6c1dbdb7b7 | 2024-11-10 | Warnings | M012 |
| dg health adult tussin | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Dolgencorp Inc | 81f12484-ddf7-49c6-b530-3a81d62ab40d | 2024-11-10 | Warnings | M012 |
| careone tussin dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Retail Business Services, LLC | 230fa1ea-ae7c-425e-8447-79a90c96ae9e | 2024-11-10 | Warnings | M012 |
| good sense tussin dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | L. Perrigo Company | cb8a1d81-b1a3-4217-b157-9e5d398f202d | 2024-11-09 | Warnings | M012 |
| PhysiciansCare Allergy Antihistamine | DIPHENHYDRAMINE HYDROCHLORIDE | Acme United Corporation | 5e31b1ff-291f-7b8c-e053-2a91aa0aedbc | 2024-11-09 | Warnings | M012 |
| Duraflu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PSEUDOEPHEDRINE HCL | Poly Pharmaceuticals, Inc. | 55fffc1d-8449-4c28-a391-c6f60dd85622 | 2024-11-09 | Warnings | M012 |
| Poly-Vent IR | GUAIFENESIN AND PSEUDOEPHEDRINE HCL | Poly Pharmaceuticals, Inc. | ce0d8c45-446a-4df4-a36b-5000ba69d30d | 2024-11-09 | Warnings | M012 |
| basic care tussin dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Amazon.com Services LLC | 306d5914-03ed-410a-9345-c54ba604e991 | 2024-11-09 | Warnings | M012 |
| care one nasal original | OXYMETAZOLINE HYDROCHLORIDE | American Sales Company | a0c35e06-c9e9-438e-8224-d4760b6e2aff | 2024-11-09 | Warnings | M012 |
| adult tussin dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Walgreen Company | 34174507-cf2e-4ed4-85ec-f915d4b910df | 2024-11-08 | Warnings | M012 |
| Childrens Benadryl Chewables | DIPHENHYDRAMINE HYDROCHLORIDE | Kenvue Brands LLC | b08f71d8-a06c-41ba-8ed1-fbc41dbc1919 | 2024-11-08 | Warnings | M012 |
| SUDAFED PE SINUS CONGESTION | DIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | a38fdfb8-db89-487f-9b68-aa9152b91f5f | 2024-11-08 | Warnings | M012 |
| SUDAFED Sinus Congestion | PSEUDOEPHEDRINE HYDROCHLORIDE | Kenvue Brands LLC | c05d7e27-6821-468f-b27d-9c0b02a07b0f | 2024-11-08 | Warnings | M012 |
| Benadryl | DIPHENHYDRAMINE HYDROCHLORIDE | Kenvue Brands LLC | 2884d2dc-2d4a-4ca6-ab73-688a80b428eb | 2024-11-08 | Warnings | M012 |
| Extra Strength TYLENOL Cold plus Flu Multi-Action Day/Night | ACETAMINOPHEN, PSEUDOEPHEDRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND CHLORPHENIRAMINE MALEATE | Kenvue Brands LLC | 712ba011-79aa-469b-9f0f-04a0b4b705bd | 2024-11-08 | Warnings | M012 |
| SUDAFED PE Pressure Plus Pain | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 8538c291-9ce9-4866-b268-f4cbdb52f5bd | 2024-11-08 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1116568 | acetaminophen 650 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 20 mL Oral Solution | PSN | 263dae13-5f92-4505-8bcc-e903d05b9a0c | 1 |
| 1116568 | acetaminophen 32.5 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | 263dae13-5f92-4505-8bcc-e903d05b9a0c | 1 |
| 1116568 | acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution | SY | 263dae13-5f92-4505-8bcc-e903d05b9a0c | 1 |
| 1116568 | acetaminophen 650 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution | SY | 263dae13-5f92-4505-8bcc-e903d05b9a0c | 1 |
| 1116568 | APAP 32.5 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Solution | SY | 263dae13-5f92-4505-8bcc-e903d05b9a0c | 1 |
| 1116568 | APAP 650 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution | SY | 263dae13-5f92-4505-8bcc-e903d05b9a0c | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 76281-515-25 | 76281051525 | 177 mL in 1 BOTTLE (76281-515-25) | 177 ml | 2024-01-30 | No | No | Current |