Severe Congestion and Sinus Relief
- Product NDC
- 49035-478
- 11-digit product format
- 490350478
- Labeler code
- 49035
- Product ID
- 49035-478_c7b5c2f1-fffe-4b05-9dd8-0b5f4417d6a5
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Guaifenesin, Phenylephrine HCl
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2018-04-30
- Marketing end
- 2026-12-28
- 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
- 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
- Severe Congestion and Sinus Relief
- Brand name suffix
- Maximum Strength
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 650 mg/20mL |
| GUAIFENESIN | 400 mg/20mL |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/20mL |
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 |
| 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 |
| 4fe95224-f543-4dbb-9445-8cca122b48c8 | Product name | 1 | 20150609 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 106ff02a-57e1-4c4c-a307-fd582ff4e311 | Product name | 1 | 20150212 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49035-478-06 | Severe Congestion and Sinus ReliefMaximum Strength | 177 mL in 1 BOTTLE, PLASTIC | LIQUID | 177 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 49035-478 | SEVERE CONGESTION AND SINUS RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EQUATE (WAL-MART STORES, INC.) (SEE ALSO WAL-MART INC)] | 4 | Current NDC, Legacy NDC, 1 package rows | 20240323_aaccafe6-2e76-4023-a5d8-bcec27f60f08.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 |
|---|---|---|---|---|---|---|
| Medi-First Sinus Decongestant | PHENYLEPHRINE HYDROCHLORIDE | Unifirst First Aid Corporation | 9654f5cd-74d7-44a2-9674-666d1e94ffa7 | 2025-09-08 | Warnings | M012 |
| Otis Clapp Mygrex | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE | Unifirst First Aid Corporation | f196f2c5-a100-42b1-bd01-0327b223838e | 2025-09-08 | Warnings | M012 |
| Medique Diphen | DIPHENHYDRAMINE HYDROCHLORIDE | Unifirst First Aid Corporation | b61ee2e0-2543-447d-9fc4-23363d46ce04 | 2025-09-08 | Warnings | M012 |
| Green Guard Allergy 2 Relief | PHENYLEPHRINE HYDROCHLORIDE | Unifirst First Aid Corporation | 16fddca9-a66b-41e6-9423-eaf091d3971e | 2025-09-08 | Warnings | M012 |
| Medique Medi-Phenyl | PHENYLEPHRINE HYDROCHLORIDE | Unifirst First Aid Corporation | d7d62ac1-1333-4366-884b-26537766ce38 | 2025-09-08 | Warnings | M012 |
| Unishield Sinus Decongestant | PHENYLEPHRINE HCL | Unishield | b8f68d9d-2d38-414a-e053-2a95a90a15ec | 2025-09-08 | Warnings | M012 |
| McKesson Sinus Pain and Pressure Relief | ACETAMINOPHEN, PHENYLEPHRINE HCL | McKesson Medical-Surgical | e0cbb213-4f4f-4045-e053-2a95a90a2a18 | 2025-09-08 | Warnings | M012 |
| Medique Medicidin D | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE | Unifirst First Aid Corporation | 1f172d58-4050-424b-9743-130d8e618fe8 | 2025-09-08 | Warnings | M012 |
| Medique Cold Cough Product | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL , | Unifirst First Aid Corporation | e8059137-efba-398c-e053-2a95a90a21f2 | 2025-09-08 | Warnings | M012 |
| Medique Medi-Mucus | DEXTROMETHORPHAN HBR, GUAIFENESIN | Unifirst First Aid Corporation | f3bb862a-9cb8-f644-e053-2a95a90a5f4f | 2025-09-08 | Warnings | M012 |
| Physicians Care Cough and Sore Throat | MENTHOL | Acme United Corporation | 4e02223d-f34b-333e-e054-00144ff8d46c | 2025-09-08 | Warnings | M012 |
| Physicians Care Non-Drowsy Cold and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Acme United | 186ec543-1f23-75d6-e063-6294a90a46b9 | 2025-09-08 | Warnings | M012 |
| PhysiciansCare Sinus Non-Drowsy | PHENYLEPHRINE HCL | Acme United Corporation | a6daf3ef-f386-4de4-b38e-d0b90c9ae62b | 2025-09-08 | Warnings | M012 |
| PhysiciansCare Allergy Multi-Symptom Relief | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE | Acme United Corporation | fd101c27-6ba9-4cd3-baec-a354504c37a0 | 2025-09-08 | Warnings | M012 |
| Green Guard Honey Lemon Cough Drop | MENTHOL 8.6 MG | Unifirst First Aid Corporation | 8a94f090-61d6-4909-e053-2995a90aee38 | 2025-09-08 | Warnings | M012 |
| Green Guard Cough Drop Relief | MENTHOL | Unifirst First Aid Corporation | 0fc4cb11-8ff9-4eff-9588-c73eef4e0137 | 2025-09-08 | Warnings | M012 |
| Multi-Symptom Cold Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL , GUAIFENESIN, , | Unifirst First Aid Corporation | e6ea6faf-baff-a130-e053-2a95a90a085a | 2025-09-08 | Warnings | M012 |
| MEDIQUE Medikoff Drops | MENTHOL | Unifirst First Aid Corporation | 0d6b4443-16a1-4851-bb03-d7407167551d | 2025-09-08 | Warnings | M012 |
| Medique Sugar Free Medikoff Drops | MENTHOL | Unifirst First Aid Corporation | 92d13e19-4e7b-4565-970e-504abf02579a | 2025-09-08 | Warnings | M012 |
| Medique at Home Diphen | DIPHENHYDRAMINE HCL | Unifirst First Aid Corporation | b56d1966-efd7-56eb-e053-2995a90a89b5 | 2025-09-08 | 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 | aaccafe6-2e76-4023-a5d8-bcec27f60f08 | 4 |
| 1116568 | acetaminophen 32.5 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | aaccafe6-2e76-4023-a5d8-bcec27f60f08 | 4 |
| 1116568 | acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution | SY | aaccafe6-2e76-4023-a5d8-bcec27f60f08 | 4 |
| 1116568 | acetaminophen 650 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution | SY | aaccafe6-2e76-4023-a5d8-bcec27f60f08 | 4 |
| 1116568 | APAP 32.5 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Solution | SY | aaccafe6-2e76-4023-a5d8-bcec27f60f08 | 4 |
| 1116568 | APAP 650 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution | SY | aaccafe6-2e76-4023-a5d8-bcec27f60f08 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 49035-478-06 | 49035047806 | 177 mL in 1 BOTTLE, PLASTIC (49035-478-06) | 177 ml | 2018-04-30 | 2026-12-28 | No | No | Current |