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 |
|---|---|---|---|---|---|---|
| Guaifenesin | GUAIFENESIN | Bryant Ranch Prepack | 1e9887f6-209f-4f1f-9afa-a5ca649721cb | 2026-03-18 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Famora Inc. | 5a7bf4cd-1d44-424d-9ef4-d484e626e326 | 2026-03-18 | Warnings | M012 |
| Harris Teeter Menthol Cough Drops | MENTHOL | Harris Teeter | 4d502c1f-7307-ac50-e063-6294a90a6ff4 | 2026-03-18 | Warnings | M012 |
| Harris Teeter Cherry Cough Drops | MENTHOL | Harris Teeter | 4d50cc62-c84f-0761-e063-6394a90af54a | 2026-03-18 | Warnings | M012 |
| Harris Teeter Honey Lemon Cough Drops | MENTHOL | Harris Teeter | 4d516fce-d219-eee9-e063-6294a90ac59a | 2026-03-18 | Warnings | M012 |
| Harris Teeter SF Honey Lemon Cough Drops | MENTHOL | Harris Teeter | 4d524b45-260e-7411-e063-6294a90af639 | 2026-03-18 | Warnings | M012 |
| Guaifenesin and Dextromethorphan Hydrobromide | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | Bryant Ranch Prepack | 9a77465c-6d3a-4399-9734-ad22e4b435db | 2026-03-18 | Warnings | M012 |
| good sense childrens cold cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | Preferred Pharmaceuticals Inc. | a56d2fe4-5bea-4668-8e66-5a6f4279d461 | 2026-03-18 | Warnings | M012 |
| Mucus Relief DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Cardinal Health 110, LLC. DBA Leader | 4136e5f4-cc00-46d6-aa7f-ef56d087d7ec | 2026-03-18 | Warnings | M012 |
| M-Dryl | DIPHENHYDRAMINE HYDROCHLORIDE | Bryant Ranch Prepack | f9a0fb35-46d6-434f-8f9a-425a4bf50e84 | 2026-03-18 | Warnings | M012 |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | Grocery Outlet | 7398a372-7679-423b-a3ca-8da905a979dd | 2026-03-17 | Warnings | M012 |
| Allergy Relief | ALLERGY RELIEF | Grocery Outlet | 0661ddeb-6289-471e-af89-7f4b7452c355 | 2026-03-16 | Warnings | M012 |
| Daytime Cold and Cough Nighttime Cold and Congestion | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | CVS | 2cf361eb-6055-2364-e063-6294a90a69a1 | 2026-03-16 | Warnings | M012 |
| Severe Cold and Flu Relief Daytime/Nighttime | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS PHARMACY | b024ab38-e5da-4f5a-888f-e2a281578290 | 2026-03-16 | Warnings | M012 |
| good neighbor pharmacy night time cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Amerisource Bergen | 41f87d59-3245-46dc-88a8-b947675a90fc | 2026-03-16 | Warnings | M012 |
| Childrens Cold and Cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN, PHENYLEPHRINE HCL | CVS | 2bc3eae8-ffe6-bc96-e063-6394a90a2283 | 2026-03-16 | Warnings | M012 |
| Daytime Nighttime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | CVS HEALTH CORP | 23e2d2dc-12d4-294d-e063-6394a90a9523 | 2026-03-16 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | CVS Pharmacy | 48438525-e49f-9303-e063-6394a90a44f2 | 2026-03-16 | Warnings | M012 |
| Daytime | ACETAMINOPHEN, GUAIFENESIN | CVS HEALTH CORP | 4985c332-6602-fd2d-e063-6394a90accd2 | 2026-03-16 | Warnings | M012 |
| Daytime Cold and Flu and Nighttime Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | CVS Pharmacy | 4981bbcd-7178-335f-e063-6394a90ae961 | 2026-03-16 | 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 |