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 |
|---|---|---|---|---|---|---|
| foster and thrive daytime severe cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Sportpharm LLC | 51e34704-5e6b-4e80-836c-ddbc24a451b2 | 2026-03-06 | Warnings | M012 |
| Medi-First Plus Sinus Decongestant | PHENYLEPHRINE HYDROCHLORIDE | Sportpharm LLC | 20f58b0b-c123-477f-a62c-fa5423e23f93 | 2026-03-06 | Warnings | M012 |
| Nasal Decongestant PE Maximum Strength | PHENYLEPHRINE HCL | Sportpharm LLC | 7f4e8d37-8c6b-4849-b86c-4335a0bcac1c | 2026-03-06 | Warnings | M012 |
| Daytime and Nighttime Cold and Flu Kit | DAYTIME AND NIGHTTIME COLD AND FLU KIT | Allegiant Health | 0533db78-7809-46ea-9998-deb5f6f1d0d9 | 2026-03-06 | Warnings | M012 |
| Nasal Decongestant PE | PHENYLEPHRINE HCL | Better Living Brands, LLC | 0153294d-7f52-4d92-8db8-daeca3e29a3b | 2026-03-06 | Warnings | M012 |
| Mucus DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Meijer Distribution, Inc. | 87cf4f25-b0e9-4f8b-bde3-0d0f26e2120e | 2026-03-06 | Warnings | M012 |
| RYNEX PE | BROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL | EDWARDS PHARMACEUTICALS, INC. | 77ae1cf6-b8e5-4f3c-b7bc-e2609a8991ef | 2026-03-05 | Warnings | M012 |
| Childrens Cold and Allergy | BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | Best Choice (Valu Merchandisers Company) | 042f9449-4af0-4b15-bb3e-236afeb1e11f | 2026-03-05 | Warnings | M012 |
| Mucus Relief | GUAIFENESIN | Amerisource Bergen | 087a3a0b-8d3f-45ed-8807-0af47b446cac | 2026-03-05 | Warnings | M012 |
| Mucus Relief DM | DEXTROMETHORPHAN HBR 20MG GUAIFENESIN 400MG | NUVICARE LLC | 6c4bc7d1-09d9-4311-8457-a1d47ab02a5a | 2026-03-05 | Warnings | M012 |
| Allergy Relief childrens | DIPHENHYDRAMINE HCL | WALMART INC. | dceb99a9-4aa3-4acc-b632-9a4ba8c87919 | 2026-03-04 | Warnings | M012 |
| AMAZON Childrens Multi Symptom Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | AMAZON.COM SERVICES LLC | 26101105-a6cf-4b51-a639-9d078542fea3 | 2026-03-04 | Warnings | M012 |
| Allergy Relief Childrens | DIPHENHYDRAMINE HCL | Major Pharmaceuticals | 3a976e90-c6af-4414-984e-9987158c9e98 | 2026-03-04 | Warnings | M012 |
| Childrens Allergy | DIPHENHYDRAMINE HCL | Best Choice (Valu Merchandisers Company) | 714e93ec-0aa9-4be2-9311-399e82f148e0 | 2026-03-04 | Warnings | M012 |
| Cold and Flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Best Choice (Valu Merchandisers Company) | d1131759-dd2e-4c06-bb73-92dd975f5511 | 2026-03-04 | Warnings | M012 |
| AMAZON Maximim Strength Adult Nighttime Cough DM | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | AMAZON.COM SERVICES LLC | 6bbe8cc9-7a60-4476-b5cf-b13c5bebff26 | 2026-03-04 | Warnings | M012 |
| Severe Cold and Flu Daytime, Nighttime | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 5a1dfaf3-370d-4ac7-a72d-a48863a35741 | 2026-03-04 | Warnings | M012 |
| Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Walgreen Company | c5cb09d4-c049-461c-8898-2c5bb6a8a138 | 2026-03-04 | Warnings | M012 |
| Tussin CF | DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCL | WinCo Foods, LLC | 3d96d6d0-8c04-43bb-aed0-4cd00cdf3456 | 2026-03-04 | Warnings | M012 |
| DayTime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | H E B | e2994c0f-add8-4f75-a6d2-24cd2af271e4 | 2026-03-03 | 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 |