FDA.reportPublic FDA data

daytime severe cold

Product NDC
41163-503
11-digit product format
411630503
Labeler code
41163
Product ID
41163-503_0048183a-ab4a-442e-8f89-63e1f0c7f020
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2005-08-04
Marketing end
2026-11-30
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], 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
daytime severe cold
Brand name suffix
multi-symptom

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
DEXTROMETHORPHAN HYDROBROMIDE10 mg/1
GUAIFENESIN200 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
9D2RTI9KYHInternal UNII lookup
495W7451VQInternal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1110988Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
cc7c5f1c-76b7-4278-8e2a-5fbc85e022ddAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41163-503-08daytime severe coldmulti-symptom12 in 1 BLISTER PACKTABLET, FILM COATED1218
41163-503-08daytime severe coldmulti-symptom2 in 1 CARTONTABLET, FILM COATED218

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41163-503-08EA - Each41163-503eadc8b5b-b307-447b-83af-95e0953d2af612013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DDAYTIME SEVERE COLD MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]5
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHDAYTIME SEVERE COLD MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]5
GUAIFENESINACTIVE INGREDIENT495W7451VQDAYTIME SEVERE COLD MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]5
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJDAYTIME SEVERE COLD MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]5
ACETAMINOPHENACTIVE MOIETY362O9ITL9DDAYTIME SEVERE COLD MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]5
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSDAYTIME SEVERE COLD MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]5
GUAIFENESINACTIVE MOIETY495W7451VQDAYTIME SEVERE COLD MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]5
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVDAYTIME SEVERE COLD MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDAYTIME SEVERE COLD MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DAYTIME SEVERE COLD MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]5
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DDAYTIME SEVERE COLD MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADAYTIME SEVERE COLD MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]5
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990DAYTIME SEVERE COLD MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]5
POVIDONESINACTIVE INGREDIENTFZ989GH94EDAYTIME SEVERE COLD MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DAYTIME SEVERE COLD MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]5
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDAYTIME SEVERE COLD MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]5
TALCINACTIVE INGREDIENT7SEV7J4R1UDAYTIME SEVERE COLD MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDAYTIME SEVERE COLD MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-503DAYTIME SEVERE COLD MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [UNITED NATURAL FOODS, INC. DBA UNFI]18Current NDC, Legacy NDC, 2 package rows20250426_cc7c5f1c-76b7-4278-8e2a-5fbc85e022dd.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 154 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Topcare Nasal Decongestant Maximum Strength Non DrowsyPSEUDOEPHEDRINE HCLTopco Associates LLC1a9e0336-c0c2-43f8-aeea-668d4a2097142024-09-20WarningsExact identifier
application number: M012
Leader Nasal DecongestantPSEUDOEPHEDRINE HCLCardinal Health 110, LLC. dba Leader25609b66-047c-46e7-bc95-20eb8e6c96172024-09-20WarningsExact identifier
application number: M012
equaline nasalPHENYLEPHRINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFI67fdd277-7a7a-4404-8ca2-39802c46405f2024-09-20WarningsExact identifier
application number: M012
equaline tussinDEXTROMETHORPHAN HBR, GUAIFENESINUnited Natural Foods, Inc. dba UNFI8bc7fa7c-d565-48c9-9808-1042c3e9d4282024-09-20WarningsExact identifier
application number: M012
Leader Adult Tussin Mucus and Chest Congestion 541GUAIFENESINCARDINAL HEALTH 110, LLC. DBA LEADERd7fae410-9c1c-4231-9fde-2c51ad3d7e952024-09-20WarningsExact identifier
application number: M012
sinusPSEUDOEPHEDRINE HYDROCHLORIDEKroger Company18812f2a-9b66-45a7-9631-123da6fd1c1f2024-09-20WarningsExact identifier
application number: M012
Good Sense Nasal FourPHENYLEPHRINE HYDROCHLORIDEL. Perrigo Company930469c1-384c-4440-b3e6-9dcd674871c42024-09-19WarningsExact identifier
application number: M012
Cold and Flu Relief Multi Symptom NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEWinCo Foods, LLC89272d2d-5533-4ae8-865b-cb204cec6d652024-09-17WarningsExact identifier
application number: M012
Cold and Flu Relief Multi Symptom NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEWinCo Foods, LLC5791c1c7-f614-4940-a45a-6291742e1e222024-09-17WarningsExact identifier
application number: M012
nasal decongestantOXYMETAZOLINE HYDROCHLORIDESafeway2affd44d-2125-4a1f-919c-c082e7644ea82024-09-17WarningsExact identifier
application number: M012
DAYTIME COLD AND FLU RELIEF SOFTGELS NON-DROWSYACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINEAdvanced Rx LLCfa1a4d86-87bb-0c50-e053-6394a90a56e22024-09-13WarningsExact identifier
application number: M012
NIGHTTIME COLD AND FLU RELIEF SOFTGELS MULTI-SYMPTOMACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAdvanced Rx LLCfa1b60b1-49cb-1211-e053-6394a90a0a462024-09-13WarningsExact identifier
application number: M012
nasalPHENYLEPHRINE HYDROCHLORIDEWalgreen Company8db7df1c-46b5-49bd-9002-50b12d58001a2024-09-13WarningsExact identifier
application number: M012
meijer Daytime Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEMeijer, Inc.1bdd7f8a-93ce-5309-e063-6294a90a91f02024-09-12WarningsExact identifier
application number: M012
oxymetazoline hclOXYMETAZOLINE HYDROCHLORIDEPadagis Israel Pharmaceuticals Ltda1103cd8-344b-4a65-8a60-3c7be86d01a62024-09-11WarningsExact identifier
application number: M012
Good Sense NasalOXYMETAZOLINE HYDROCHLORIDEL. Perrigo Company276d7d3c-c4a7-4754-8845-c38f85aac5f72024-09-08WarningsExact identifier
application number: M012
foster and thrive nasalOXYMETAZOLINE HYDROCHLORIDEStrategic Sourcing Services LLC4ff5a4ae-9649-4a6d-a5f8-ca23efbbb4792024-09-08WarningsExact identifier
application number: M012
equate nasal originalOXYMETAZOLINE HYDROCHLORIDEWal-Mart Stores Inc7e40c9b8-e0b5-448a-a674-72388fbab1892024-09-08WarningsExact identifier
application number: M012
Anefrin Nasal OriginalOXYMETAZOLINE HYDROCHLORIDEWalgreen Company85b442dc-1703-4fef-948a-fad7cbe9f2242024-09-07WarningsExact identifier
application number: M012
equaline nasalOXYMETAZOLINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFI07e0328e-1912-4f25-9e1e-9482d4665be02024-09-07WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1110988acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSNcc7c5f1c-76b7-4278-8e2a-5fbc85e022dd18
1110988acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDcc7c5f1c-76b7-4278-8e2a-5fbc85e022dd18
1110988APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSYcc7c5f1c-76b7-4278-8e2a-5fbc85e022dd18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-503-08411630503082 BLISTER PACK in 1 CARTON (41163-503-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2005-08-042026-11-30NoNoCurrent