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 |
|---|---|---|---|---|---|---|
| Cold and Allergy | CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | DOLGENCORP, LLC | b55452e1-25d0-4db5-9621-83f21ec6c298 | 2026-04-06 | Warnings | M012 |
| Allergy Relief | CHLORPHENIRAMINE MALEATE | Strategic Sourcing Services LLC | c9fa8d93-d9d6-4206-a13d-32b9e7555e7f | 2026-04-02 | Warnings | M012 |
| Sinus Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Kroger Company | 6aaed3fe-ce35-4533-aea4-80096ce8e57a | 2026-04-02 | Warnings | M012 |
| Nasal Four | PHENYLEPHRINE HYDROCHLORIDE | HyVee Inc | 19879fc8-4962-4c6e-87ed-b874d1d564af | 2026-04-01 | Warnings | M012 |
| Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Lidl US LLC | 7227b330-590b-4731-8a58-e05a0233dd8a | 2026-04-01 | Warnings | M012 |
| SudoGest | CHLORPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL | Major Pharmaceuticals | 7cd8f7f3-c262-4f7c-bcaf-068be2c952f9 | 2026-04-01 | Warnings | M012 |
| Sanatos Daytime Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Pharmadel LLC | 4c26be18-733a-e4a8-e063-6294a90a8b02 | 2026-04-01 | Warnings | M012 |
| Sanatos Nighttime Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Pharmadel LLC | 4c26c8bf-0143-ddca-e063-6294a90a3552 | 2026-04-01 | Warnings | M012 |
| Codeine-Guaifenesin | CODEINE PHOSPHATE AND GUAIFENESIN | Method Pharmaceuticals, LLC | fe126254-6ee6-48c3-965c-96e4276a5314 | 2026-04-01 | Warnings | M012 |
| Good Neighbor Pharmacy Mucus Relief | GUAIFENESIN | AmerisourceBergen Drug Corp | 200dddd9-e3ff-4cec-a164-d1c9a698f121 | 2026-03-31 | Warnings | M012 |
| Head and Cold | ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Hi-Tech Nutraceuticals, LLC | a39c772b-3cce-14cb-e053-2a95a90a733b | 2026-03-31 | Warnings | M012 |
| diphenhydramine hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | 44217a8c-7656-a0f6-e063-6294a90af2ad | 2026-03-31 | Warnings | M012 |
| Dr Kids Cough and Chest Congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN | CalmCo LLC | 3f156679-7a91-aff1-e063-6394a90a18f6 | 2026-03-31 | Warnings | M012 |
| Codeine-Guaifenesin | CODEINE PHOSPHATE AND GUAIFENESIN | A-S Medication Solutions | c26da6e0-ab1c-46c2-acf5-0074958c03cd | 2026-03-31 | Warnings | M012 |
| Flu HBP Maximum Strength | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Cardinal Health 110, LLC. DBA Leader | ba174fcc-da1e-420c-bf9c-179ad65c2848 | 2026-03-31 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Amerisource Bergen | 8e0c6f8d-559c-45de-9362-1b713fd78a7a | 2026-03-30 | Warnings | M012 |
| Dr. Simi Daytime Cold and Flu | ACETAMINOPHEN 325 MG, DEXTROMETHORPHAN HBR 10 MG, PHENYLEPHRINE HCL 5 MG | Farmacias De Similares TX LLC | 4e448fd0-cb6b-b69b-e063-6394a90afde8 | 2026-03-30 | Warnings | M012 |
| Dr. Simi Nighttime Cold and Flu | ACETAMINOPHEN 325 MG, DEXTROMETHORPHAN HBR 15 MG, DOXYLAMINE SUCCINATE 6.25 MG | Farmacias De Similares TX LLC | 4e5772ee-586c-6191-e063-6294a90a132d | 2026-03-30 | Warnings | M012 |
| allergy | DIPHENHYDRAMINE HCL | HyVee Inc | 75b19163-db1c-42fc-8bbb-364be16b9b2f | 2026-03-30 | Warnings | M012 |
| nasal | OXYMETAZOLINE HYDROCHLORIDE | HyVee Inc | a9f23c63-eeda-4de9-aec6-fe482f469e98 | 2026-03-27 | 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 |