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 |
|---|---|---|---|---|---|---|
| Premier Value | COUGH DROPS CHERRY | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 2a2de803-900d-02f4-e063-6394a90a84cc | 2025-12-29 | Warnings | M012 |
| QUALITY CHOICE | COUGH DROPS HONEY LEMON SUGAR FREE | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 2307f3a7-f6e7-8a5d-e063-6394a90ab7eb | 2025-12-29 | Warnings | M012 |
| Premier Value | COUGH DROPS MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 2a2e8fbe-c1c3-79b1-e063-6394a90a4d73 | 2025-12-29 | Warnings | M012 |
| Premier Value | COUGH DROPS HONEY LEMON | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 2a2dfcc3-e599-3102-e063-6394a90ad54a | 2025-12-29 | Warnings | M012 |
| Premier Value | COUGH DROPS BLACK CHERRY SUGAR FREE | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 2a2ead3c-b4d5-ee8f-e063-6294a90a3c39 | 2025-12-29 | Warnings | M012 |
| MGC Health | COUGH DROPS CREAMY STRAWBERRY | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 29f42644-045b-c4b3-e063-6294a90a48fd | 2025-12-29 | Warnings | M012 |
| MGC Health | COUGH DROPS VANILLA HONEY | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 29f45499-bf14-03e4-e063-6394a90a535c | 2025-12-29 | Warnings | M012 |
| MGC Health | COUGH DROPS BLACK CHERRY SUGAR FREE | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 29f3ddcc-9d4e-f1b1-e063-6294a90ac86f | 2025-12-29 | Warnings | M012 |
| Menthol Flavor Cough Drop | MENTHOL FLAVOR COUGH DROP | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 274a5551-4989-d8fe-e063-6394a90aeabf | 2025-12-29 | Warnings | M012 |
| MENTHOL COUGH SUPPRESSANT ORAL ANESTHETIC Cough Drops | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 29f2acaa-2cc8-a999-e063-6294a90a15ce | 2025-12-29 | Warnings | M012 |
| Leader Throat Soothing Drops Creamy Strawberry | THROAT SOOTHING CREAMY STRAWBERRY | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 26a92ecc-6a9c-b569-e063-6394a90a8bcb | 2025-12-29 | Warnings | M012 |
| ValuMeds Allergy Relief Antihistamine Diphenhydramine HCl | DIPHENHYDRAMINE HYDROCHLORIDE | Cabinet Health P.B.C. | a5ceab90-6885-4f3a-b001-97679e03c01b | 2025-12-29 | Warnings | M012 |
| Goodmeds Non-Drowsy Cough Relief | DEXTROMETHORPHAN HYDROBROMIDE | Cabinet Health P.B.C. | 32482083-3f51-41f4-8d20-bedf143e066d | 2025-12-29 | Warnings | M012 |
| Tusnel EX | GUAIFENESIN | Llorens Pharmaceutical International Division, Inc. | 77c16288-68c4-476c-995f-86f505663270 | 2025-12-29 | Warnings | M012 |
| Tusnel DM | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Llorens Pharmaceutical International Division, Inc. | fe457e6d-422d-496c-bcb9-33594f3c42ff | 2025-12-29 | Warnings | M012 |
| Tusnel Diabetic | DEXTROMETHORPHAN, GUAIFENESIN | LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION | 66b3c094-809e-4d2c-bc15-46563de685cb | 2025-12-29 | Warnings | M012 |
| Fortify | MENTHOL | Natures Formulae Health Products Ltd. | 781d53cf-b3dc-3e2b-e053-2a91aa0a7dcd | 2025-12-29 | Warnings | M012 |
| Safetussin PM Nighttime Cough relief | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Kramer Laboratories | 33dd2245-9abd-4b32-ac76-0f45a54c0f33 | 2025-12-29 | Warnings | M012 |
| Winco Foods Medicated Chest Rub | CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL | WinCo Foods, LLC | f54eb60d-c602-1272-e053-2995a90aa95a | 2025-12-28 | Warnings | M012 |
| Gencare-Nasal Decongestant PE | PHENYLEPHRINE HYDROCHLORIDE | Pioneer Life Sciences, LLC | ad4d74a8-a762-4378-9016-f7c83421073e | 2025-12-26 | 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 |