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 |
|---|---|---|---|---|---|---|
| MedPride Chest Rub | CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL | Shield Line LLC | 85cd2fb8-d688-c3a3-e053-2991aa0ac18c | 2025-08-20 | Warnings | M012 |
| Adult Cough and Chest Congestion Relief DM Non Drowsy | DEXTROMETHORPHAN HBR, GUAIFENESIN | Safeway, Inc. | 5bd508a0-2f75-413e-a690-bed970131bef | 2025-08-19 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | BJWC (Berkley & Jensen / BJ's) | 2f32d32e-e92c-ea57-e063-6394a90a4c39 | 2025-08-19 | Warnings | M012 |
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Rite Aid Corporation | 0eff2050-2d15-40cf-b96d-666d1dd83120 | 2025-08-19 | Warnings | M012 |
| Daytime Cold and Flu Non Drowsy | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Rite Aid Corporation | 09bd88ec-ff84-4640-b561-243fda727043 | 2025-08-19 | Warnings | M012 |
| Daytime Nighttime Sinus Relief Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL,GUAIFENESIN | CVS Pharmacy | 1de2a7fd-129e-4b7b-a9bf-7a5811367bbf | 2025-08-18 | Warnings | M012 |
| Night Time Cold and Flu Relief Multi Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Rite Aid Corporation | 28785677-2e80-4d6e-8997-bf5ac2ffb5a2 | 2025-08-18 | Warnings | M012 |
| Daytime Mucus Relief Severe Cold and Nighttime Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL,GUAIFENESIN | CVS Pharmacy | 2b7c5b5a-ebe3-4381-bb71-2359bc553df5 | 2025-08-18 | Warnings | M012 |
| ACTIDOGESIC | DEXBROMPHENIRAMINE MALEATE, ACETAMINOPHEN | ACTIPHARMA, LLC | 697da3f9-9888-4d41-ba83-87ca9bf1e54b | 2025-08-18 | Warnings | M012 |
| Night Time Cold and Flu Relief Multi Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Rite Aid Corporation | 5f9c9c48-4e8f-4ace-a6fb-1c1bccaf02a0 | 2025-08-18 | Warnings | M012 |
| MAJOR NASAL DECONGESTANT | OXYMETAZOLINE HYDROCHLORIDE | A-S Medication Solutions | 4b78b9af-0975-43f8-8b44-daddef0478be | 2025-08-15 | Warnings | M012 |
| Dr Simi Mucus Relief Expectorant | GUAIFENESIN | Farmacias De Similares TX LLC | 3c6d0e75-a685-6020-e063-6294a90a5c1b | 2025-08-15 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Rite Aid Corporation | 25bf4390-23f7-4bb6-b86e-c40eaf8d92da | 2025-08-15 | Warnings | M012 |
| Childrens Chewable Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | KROGER COMPANY | 2cac72be-4830-ad49-e063-6394a90a7832 | 2025-08-14 | Warnings | M012 |
| GOOD NEIGHBOR PHARMACY MUCUS RELIEF DM MAXIMUM STRENGTH | DEXTROMETHORPHAN HBR AND GUAIFENESIN | AMERISOURCE BERGEN | 2ea1e7bf-1bb9-4627-bbd4-4a78920a8b6e | 2025-08-12 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Walmart Inc. | 16fae164-28db-8ef1-e063-6294a90ab5da | 2025-08-12 | Warnings | M012 |
| Exchange Select Cough Drops Original Herb | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | fbece335-a7e5-4732-a086-561b23741579 | 2025-08-12 | Warnings | M012 |
| MGC Health Cough Drops Original Herb | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 779ddb89-b6e2-4bfb-bcb5-8c7ec916675a | 2025-08-12 | Warnings | M012 |
| Equaline Nasal | OXYMETAZOLINE HYDROCHLORIDE | United Natural Foods, Inc. dba UNFI | d7fa1720-eac4-4e82-9401-77215ce4f545 | 2025-08-12 | Warnings | M012 |
| Diabetic Tussin DM Maximum Strength | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | MEDTECH PRODUCTS INC | a10a3b33-7503-4334-8ed7-2bb881df4327 | 2025-08-08 | 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 |