FDA.reportPublic FDA data

Cold Relief Multi-Symptom

Product NDC
36800-250
11-digit product format
368000250
Labeler code
36800
Product ID
36800-250_2889f129-f28c-1164-e063-6394a90a688d
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride
Dosage form
KIT
Labeler
TopCare
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-10-01
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cold Relief Multi-Symptom
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui1086991, 1094538, 2634560

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-250-56Cold Relief Multi-Symptom1 in 1 CARTONKIT15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DCOLD RELIEF MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [TOPCARE]1
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZCOLD RELIEF MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [TOPCARE]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHCOLD RELIEF MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [TOPCARE]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJCOLD RELIEF MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [TOPCARE]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DCOLD RELIEF MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [TOPCARE]1
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965UCOLD RELIEF MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [TOPCARE]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSCOLD RELIEF MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [TOPCARE]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVCOLD RELIEF MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [TOPCARE]1
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9COLD RELIEF MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [TOPCARE]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCOLD RELIEF MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [TOPCARE]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48COLD RELIEF MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [TOPCARE]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCOLD RELIEF MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [TOPCARE]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCOLD RELIEF MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [TOPCARE]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30COLD RELIEF MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [TOPCARE]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACOLD RELIEF MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [TOPCARE]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990COLD RELIEF MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [TOPCARE]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ECOLD RELIEF MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [TOPCARE]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3COLD RELIEF MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [TOPCARE]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4COLD RELIEF MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [TOPCARE]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCOLD RELIEF MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [TOPCARE]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCOLD RELIEF MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [TOPCARE]1
TALCINACTIVE INGREDIENT7SEV7J4R1UCOLD RELIEF MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [TOPCARE]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCOLD RELIEF MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [TOPCARE]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-250COLD RELIEF MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [TOPCARE]5Current NDC, Legacy NDC, 1 package rows20241208_de8a623f-7b10-4d56-a74b-3737e7716ffe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2634560{1 (acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet) } PackGPCKde8a623f-7b10-4d56-a74b-3737e7716ffe5
26345601 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Tablet) PackPSNde8a623f-7b10-4d56-a74b-3737e7716ffe5
1086991acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral TabletPSNde8a623f-7b10-4d56-a74b-3737e7716ffe5
1094538acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral TabletPSNde8a623f-7b10-4d56-a74b-3737e7716ffe5
1086991acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDde8a623f-7b10-4d56-a74b-3737e7716ffe5
1094538acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDde8a623f-7b10-4d56-a74b-3737e7716ffe5
26345601 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Tablet) PackSYde8a623f-7b10-4d56-a74b-3737e7716ffe5
1086991APAP 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral TabletSYde8a623f-7b10-4d56-a74b-3737e7716ffe5
1094538APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral TabletSYde8a623f-7b10-4d56-a74b-3737e7716ffe5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-250-56368000250561 KIT in 1 CARTON (36800-250-56) * 12 TABLET, COATED in 1 BLISTER PACK * 8 TABLET, COATED in 1 BLISTER PACK1 kit2011-10-010000-00-00NoNoCurrent