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 |
|---|---|---|---|---|---|---|
| WALMART DAYTIME AND NIGHTTIME MS SEVERE RELIEF VALUE PACK | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL | WAL-MART STORES INC | 888bd90a-a059-4814-bd65-6b735ecfaf3a | 2026-08-31 | Warnings | M012 |
| Severe Cold and Flu Daytime and Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Kroger | 49a98411-aa5a-6de3-e063-6294a90a148f | 2026-08-31 | Warnings | M012 |
| equate daytime nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESEN, PHENYLEPHRINE HYDROCHLORIDE | Sixarp, LLC | 5a5a6917-9fb5-e6ca-e063-6394a90af9dc | 2026-08-31 | Warnings | M012 |
| Zicam Intense Sinus Relief | OXYMETAZOLINE HYDROCHLORIDE | Church & Dwight Co., Inc. | d916f7ff-84b7-57ef-e053-2995a90a3efa | 2026-08-31 | Warnings | M012 |
| Afrin Original Nasal | OXYMETAZOLINE HYDROCHLORIDE | JC World Bell Wholesale Co., Inc. | ecfa14b8-a3f3-4569-b489-c9e1a51cf09e | 2026-08-31 | Warnings | M012 |
| Dextromethorphan HBr | DEXTROMETHORPHAN HBR | BIONPHARMA INC. | 5a5dde85-8785-8149-e063-6294a90a4d57 | 2026-08-31 | Warnings | M012 |
| Equate Nasal | OXYMETAZOLINE HCL | Sixarp, LLC | 5a5e2458-bab0-4931-e063-6394a90ad606 | 2026-08-31 | Warnings | M012 |
| MUCINEX INSTASOOTHE SORE THROAT PLUS COUGH RELIEF | DEXTROMETHORPHAN HYDROBROMIDE AND HEXYLRESORCINOL | Reckitt Benckiser LLC | 8d670d91-9e22-45b9-b568-5b62c2133d32 | 2026-08-31 | Warnings | M012 |
| Daytime Cold and Flu Multi Symptom Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Shield Pharmaceuticals Corp | e85b4c2a-d4e0-452c-9a08-fcc0ff6eaa21 | 2026-08-31 | Warnings | M012 |
| Daytime Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Shield Pharmaceuticals Corp | 67849e09-2056-4013-98b1-d003ed3250a2 | 2026-08-31 | Warnings | M012 |
| MAX Tussin Mucus and Chest Congestion Sugar Free | GUAIFENESIN | Akron Pharma Inc. | 3b023b91-e703-4599-9864-96d8c328b45c | 2026-08-31 | Warnings | M012 |
| MAX Tussin Mucus and Chest Congestion | GUAIFENESIN | Akron Pharma Inc. | ac874a31-5556-4669-937f-dcb52aaecd8a | 2026-08-31 | Warnings | M012 |
| MAX Tussin Cough and Chest Congestion DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Akron Pharma Inc. | e0ce4287-bfa1-4413-97c8-4fe2e39bda36 | 2026-08-31 | Warnings | M012 |
| Acetaminophen PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | United Natural Foods, Inc. dba UNFI | 24173e77-92ec-4a87-a471-d6867837c180 | 2026-08-31 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | DOLGENCORP, LLC | 69af44c2-390c-4223-889a-d5555aef5778 | 2026-08-28 | Warnings | M012 |
| Tussin DM Daytime | DEXTROMETHORPHAN HBR, GUAIFENESIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 432d4833-2eaf-4f7c-b6b4-41043a6b7e2a | 2026-08-28 | Warnings | M012 |
| Diphenhydramine HCl | DIPHENHYDRAMINE HCL | Major Pharmaceuticals | 93753885-6add-462c-9df8-b0a1b9ce36c9 | 2026-08-28 | Warnings | M012 |
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Your Military Exchanges | 13fcc43c-bdda-4b65-b6d7-23b39e683651 | 2026-08-28 | Warnings, Adverse reactions | M012 |
| Multi-Symptom Allergy | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | Walgreen Company | 5170c450-989d-44fa-ab38-86c78feae3b6 | 2026-08-28 | Warnings | M012 |
| Pain Reliever PM Extra strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Walgreens | 54cbbc5f-908b-47b2-b37f-3646354d3568 | 2026-08-27 | 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 |