FDA.reportPublic FDA data

Multi-Symptom Cold

Product NDC
63941-470
11-digit product format
639410470
Labeler code
63941
Product ID
63941-470_21ce7349-9242-4092-aeed-32b8e29eb9ad
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Valu Merchandisers Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2005-07-15
Marketing end
2027-08-31
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 10; 5 mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], 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

Additional Listing Data#

Finished product
Yes
Brand name base
Multi-Symptom Cold
Brand name suffix
Daytime

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
9D2RTI9KYHInternal 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
1094538Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d0f896a6-5637-45ef-bf60-b343cbcdcf7eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63941-470-08Multi-Symptom ColdDaytime12 in 1 BLISTER PACKTABLET, FILM COATED1216
63941-470-08Multi-Symptom ColdDaytime2 in 1 CARTONTABLET, FILM COATED216

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DMULTI-SYMPTOM COLD DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [VALUE MERCHANDISERS COMPANY, INC.]3
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHMULTI-SYMPTOM COLD DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [VALUE MERCHANDISERS COMPANY, INC.]3
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJMULTI-SYMPTOM COLD DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [VALUE MERCHANDISERS COMPANY, INC.]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DMULTI-SYMPTOM COLD DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [VALUE MERCHANDISERS COMPANY, INC.]3
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSMULTI-SYMPTOM COLD DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [VALUE MERCHANDISERS COMPANY, INC.]3
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVMULTI-SYMPTOM COLD DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [VALUE MERCHANDISERS COMPANY, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMULTI-SYMPTOM COLD DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [VALUE MERCHANDISERS COMPANY, INC.]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MULTI-SYMPTOM COLD DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [VALUE MERCHANDISERS COMPANY, INC.]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMULTI-SYMPTOM COLD DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [VALUE MERCHANDISERS COMPANY, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MULTI-SYMPTOM COLD DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [VALUE MERCHANDISERS COMPANY, INC.]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMULTI-SYMPTOM COLD DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [VALUE MERCHANDISERS COMPANY, INC.]3
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990MULTI-SYMPTOM COLD DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [VALUE MERCHANDISERS COMPANY, INC.]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EMULTI-SYMPTOM COLD DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [VALUE MERCHANDISERS COMPANY, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMULTI-SYMPTOM COLD DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [VALUE MERCHANDISERS COMPANY, INC.]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMULTI-SYMPTOM COLD DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [VALUE MERCHANDISERS COMPANY, INC.]3
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4MULTI-SYMPTOM COLD DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [VALUE MERCHANDISERS COMPANY, INC.]3
TALCINACTIVE INGREDIENT7SEV7J4R1UMULTI-SYMPTOM COLD DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [VALUE MERCHANDISERS COMPANY, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMULTI-SYMPTOM COLD DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [VALUE MERCHANDISERS COMPANY, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63941-470MULTI-SYMPTOM COLD DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET, FILM COATED [VALU MERCHANDISERS COMPANY]14Current NDC, Legacy NDC, 2 package rows20240704_d0f896a6-5637-45ef-bf60-b343cbcdcf7e.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 1 of 195 · 3,893 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCardinal Health 110, LLC. DBA Leader610accad-2f8b-4605-9357-a58e6e18d4172026-08-15WarningsExact identifier
application number: M012
CVS Childrens COLD PLUS COUGH PLUS SORE THROATACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDECVS PHARMACY27820bce-6638-4f17-ac66-62b02b76bec32026-08-14WarningsExact identifier
application number: M012
CVS PHARMACY Childrens Cold and AllergyBROMPHENIRAMINE MALEATECVS PHARMACY, INC.004e104b-d6ff-48d5-8685-cd1bff45399a2026-08-14WarningsExact identifier
application number: M012
CHILDRENS DIMETAPP COLD AND COUGHBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCVS PHARMACY7babf4f6-ca0a-44a7-b1ea-d60e20d36f152026-08-14WarningsExact identifier
application number: M012
CVS Mucus Relief DM and Overnight Cold and FluDEXTROMETHORPHAN HBR, GUAIFENESIN, ACETAMINOPHEN AND TRIPROLIDINE HCLCVS75520b77-d40b-4f43-b92a-7a3eba5b493f2026-08-14WarningsExact identifier
application number: M012
CVS Severe Multi-Symptom Cough Cold FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS PHARMACYbb24c298-1d00-4378-8de3-b4056220fa752026-08-14WarningsExact identifier
application number: M012
SEVERE COLD PLUS FLU DAYTIME NIGHTTIMEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATECVS Pharmacy,Inc.6cb1d08b-e544-4084-b9ed-1e0d99a709c82026-08-14Warnings, Adverse reactionsExact identifier
application number: M012
Theraflu Relief Max Strength DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBRCVS PHARMACY932a3d40-9b52-4e91-bc61-6fd506f2d9e62026-08-14WarningsExact identifier
application number: M012
Multi Symptom Severe Cold and Nighttime Severe Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLCVS Pharmacy,Inc.91063edd-1e7e-41e9-8412-b14ef37490182026-08-14WarningsExact identifier
application number: M012
CVS Childrens Cold and AllergyBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCLCVS PHARMACY, INC.f4020c08-29f6-4609-834e-191ce68851302026-08-14WarningsExact identifier
application number: M012
CVS Severe Cough, Flu Plus Sore Throat HoneyACETAMINOPHEN, DEXTROMETHORPHAN HBRCVS PHARMACY95203001-7ca6-4513-83a3-9ef17855bc0f2026-08-14WarningsExact identifier
application number: M012
Daytime Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCVS PHARMACY81d26e9c-b713-4fb3-b0a5-68526bad230e2026-08-14WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWalgreen Companye9d0b6f9-e9f3-431c-9f34-4d63108282a12026-08-13WarningsExact identifier
application number: M012
daytime nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCLAmazon.com Services LLC9bb6bbd5-508e-4781-ad1c-69ccf0a5f13e2026-08-13WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAmazon.com Services LLC1e3c81b0-05de-4c4a-8579-f301f14626b32026-08-13WarningsExact identifier
application number: M012
Tussin DM Daytime NighttimeDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDd59f6c64-8311-48ba-90d1-8000b04bfcda2026-08-13WarningsExact identifier
application number: M012
TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS DAY PLUS NIGHTACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEKenvue Brands LLC1c5578e6-7e67-c467-e063-6294a90a6e0b2026-08-12WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEAmazon.com Services LLCf95220c5-e55c-4271-a267-d004ad2447bf2026-08-12WarningsExact identifier
application number: M012
CVS PHARMACY Childrens Allergy ChewsDIPHENHYDRAMINE HCLCVS PHARMACY, INC.569b8efa-8458-49f7-a665-6b7016a105052026-08-12WarningsExact identifier
application number: M012
CVS PHARMACY DYE FREE Childrens Allergy ChewsDIPHENHYDRAMINE HCLCVS PHARMACY, INC.e6671e8b-653a-4f4e-b6f3-e31fcd14fbd72026-08-12WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094538acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral TabletPSNd0f896a6-5637-45ef-bf60-b343cbcdcf7e16
1094538acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDd0f896a6-5637-45ef-bf60-b343cbcdcf7e16
1094538APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral TabletSYd0f896a6-5637-45ef-bf60-b343cbcdcf7e16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63941-470-08639410470082 BLISTER PACK in 1 CARTON (63941-470-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2005-07-152027-08-31NoNoCurrent