FDA.reportPublic FDA data

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 table
IngredientStrength
ACETAMINOPHEN650 mg/20mL
GUAIFENESIN400 mg/20mL
PHENYLEPHRINE HYDROCHLORIDE10 mg/20mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-478-06Severe Congestion and Sinus ReliefMaximum Strength177 mL in 1 BOTTLE, PLASTICLIQUID1774

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-478SEVERE CONGESTION AND SINUS RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EQUATE (WAL-MART STORES, INC.) (SEE ALSO WAL-MART INC)]4Current NDC, Legacy NDC, 1 package rows20240323_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.

Matched openFDA labels page 124 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alka-Seltzer Plus Multi-Symptom Cold and Flu Day and Night Liquid GelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLBayer HealthCare LLC.34b2e77f-5d04-15a7-e054-00144ff8d46c2025-01-17WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold PowerFast Fizz Orange ZestASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.a23a6db6-4585-2882-e053-2a95a90ab01a2025-01-17WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold Night PowerFast FizzASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.fc754dff-cecd-fc6b-e053-6394a90ab3712025-01-17WarningsExact identifier
application number: M012
Kroger DayTime Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEThe Kroger Co.2499210b-c162-76b9-e063-6294a90adbc32025-01-17WarningsExact identifier
application number: M012
Childrens Multi Symptom Cold Very BerryDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS2a849ae9-338f-4642-e063-6394a90a1ca42025-01-17WarningsExact identifier
application number: M012
Kroger NightTime Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEThe Kroger Co.24a73de3-e9eb-4cd4-e063-6394a90aa2632025-01-17WarningsExact identifier
application number: M012
Diphenhydramine HCl Oral SolutionDIPHENHYDRAMINE HCL ORALEverpharm LLCd7aaf874-69ac-49cf-93be-6d4a38b9a5572025-01-16WarningsExact identifier
application number: M012
Cough ReliefDEXTROMETHORPHAN HBRBest Choice (Valu Merchandisers Company)204a7fc4-142d-45fd-8a77-0612857132be2025-01-16WarningsExact identifier
application number: M012
daytime cold and flu nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEMeijer, Inc.df31056b-d0eb-4094-98d9-3d444210d50d2025-01-16WarningsExact identifier
application number: M012
Childrens Ibuprofen Oral SuspensionIBUPROFENReliable 1 Laboratories LLC28dd9baa-43bd-b60a-e063-6394a90a8cf72025-01-15WarningsExact identifier
application number: M012
GuaifenesinGUAIFENESINReliable 1 Laboratories LLCae469d4f-91c4-cff0-e053-2995a90a04972025-01-15WarningsExact identifier
application number: M012
Diphenhydramine HCL 25 mgDIPHENHYDRAMINE HCLReliable 1 Laboratories LLC32f58cb3-941f-263b-e054-00144ff8d46c2025-01-15WarningsExact identifier
application number: M012
Diphenhydramine HCl 25 mgDIPHENHYDRAMINE HCLReliable 1 Laboratories LLC32fa40ad-fed5-586f-e054-00144ff88e882025-01-15WarningsExact identifier
application number: M012
CVS Health Chest Congestion and Cough HBP SOFTGELDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCVS Pharmacy, Inc2741ba44-1cc7-1812-e063-6394a90a8faa2025-01-14WarningsExact identifier
application number: M012
DAY COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTARGET CORPORATION2b941963-8a8c-4148-e063-6294a90a1dfb2025-01-13WarningsExact identifier
application number: M012
Diphenhydramine HCLDIPHENHYDRAMINE HCLSDA Laboratories, Inc.437e6a13-a4ff-4f98-8973-042f224ee85e2025-01-13WarningsExact identifier
application number: M012
Diphenhydramine HCLDIPHENHYDRAMINE HCLSDA Laboratories, Inc.6a520986-1004-4ee6-9a47-1dfd90bb1b2c2025-01-13WarningsExact identifier
application number: M012
good sense daytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLL. Perrigo Company5ddf3283-94e4-465d-842a-471ee946c3302025-01-10WarningsExact identifier
application number: M012
Vicks VapoSteamCAMPHOR (SYNTHETIC)Kaz USA, Incc28da455-07ad-4053-8b9e-fc559f9a3f722025-01-10WarningsExact identifier
application number: M012
Guaifenesin 200mgGUAIFENESINAphena Pharma Solutions - Tennessee, LLC45ac210a-8c54-4469-8e10-e6fe52b89cb52025-01-09WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1116568acetaminophen 650 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 20 mL Oral SolutionPSNaaccafe6-2e76-4023-a5d8-bcec27f60f084
1116568acetaminophen 32.5 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCDaaccafe6-2e76-4023-a5d8-bcec27f60f084
1116568acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 10 ML Oral SolutionSYaaccafe6-2e76-4023-a5d8-bcec27f60f084
1116568acetaminophen 650 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral SolutionSYaaccafe6-2e76-4023-a5d8-bcec27f60f084
1116568APAP 32.5 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral SolutionSYaaccafe6-2e76-4023-a5d8-bcec27f60f084
1116568APAP 650 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral SolutionSYaaccafe6-2e76-4023-a5d8-bcec27f60f084

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-478-0649035047806177 mL in 1 BOTTLE, PLASTIC (49035-478-06) 177 ml2018-04-302026-12-28NoNoCurrent