FDA.reportPublic FDA data

NDC 10702-017-04 - Cold FAid

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
10702-017
Requested NDC
10702-017-04
Package NDCs from labels
10702-017-06, 10702-017-24, 10702-017-01, 10702-017-04, 10702-017-54
Manufacturer
Cold FAid
Effective date
2021-01-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Chlorphen-12 - Cold FAidCold FAid2021-01-19HUMAN OTC DRUG LABEL
Chlorphen-12 (Chlorpheniramine Maleate) Extended-Release Tablets, 12 mgKVK-Tech, Inc. | Avanthi, Inc.2018-12-19HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10702-017-01Chlorphen-12100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1004
10702-017-04Chlorphen-124 in 1 PACKAGETABLET, FILM COATED, EXTENDED RE44
10702-017-06Chlorphen-1260 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE604
10702-017-24Chlorphen-1224 in 1 CARTONTABLET, FILM COATED, EXTENDED RE244
10702-017-54Chlorphen-1250 in 1 CARTONTABLET, FILM COATED, EXTENDED RE504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10702-017CHLORPHEN-12 (CHLORPHENIRAMINE MALEATE) TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.]4Current NDC, Legacy NDC, 5 package rows20181220_84409269-fe9b-469e-9a66-27b1475231a3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10702-017-06EA - Each10702-017f305b502-0c47-4323-8289-8c165c89994012013-02-13
10702-017-24EA - Each10702-01788273ebc-e706-4a95-8da1-91eb4ffe9cd612013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZCHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.]1
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965UCHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.]1
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZCHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LCHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PCHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JCHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ECHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.]1
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP0CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UCHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMCHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.]1

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 239 · 4,769 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COLTALIN-DMACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEFORTUNE PHARMACAL COMPANY LIMITED33e1bec0-323b-40b7-809a-cb65a71ad0ce2026-09-17WarningsExact identifier
unii: 04JA59TNSJ
unii: V1Q0O9OJ9Z
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRGeiss, Destin & Dunn Inc.1ea07a01-8779-48c2-a287-b7be866cce7b2026-09-10WarningsExact identifier
unii: V1Q0O9OJ9Z
Childrens Cold and Allergy ReliefBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCLStrategic Sourcing Services LLCd64fe757-9948-4727-b5dd-1f8e4e4763e22026-09-10WarningsExact identifier
unii: 04JA59TNSJ
Cold and Flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATEKroger Companyfd41e4a4-330f-4409-8ba3-0b3bb6f45bca2026-09-10WarningsExact identifier
unii: V1Q0O9OJ9Z
Mucus Relief Cold Flu and Sore Throat Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRaritan Pharmaceuticals Inc2cb3e17f-3858-4773-a53f-0860ae6ff1b92026-09-09WarningsExact identifier
unii: 04JA59TNSJ
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: 532B59J990
unii: FZ989GH94E
severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDERite Aid Corporation4b8ae971-ab57-4937-a878-72d905d7b8492026-09-09WarningsExact identifier
unii: 04JA59TNSJ
Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCARDINAL HEALTH 110, LLC. DBA LEADER 7000082ba9a73-60ef-49fd-960f-5ca2bb79555e2026-09-09WarningsExact identifier
unii: 04JA59TNSJ
DRx Choice Childrens Stuffy Nose and Chest CongestionGUAIFENESIN AND PHENYLEPHRINE HCLRARITAN PHARMACEUTICALS7a3bb739-ff50-4d29-b270-d6b0849064932026-09-09WarningsExact identifier
unii: 04JA59TNSJ
Mucus Relief Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRaritan Pharmaceuticals Inc8a166067-b492-4742-b74c-28fac87c8d702026-09-09WarningsExact identifier
unii: 04JA59TNSJ
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMRite Aid Corporation407c78ca-6fee-4ed6-b61b-711ec049c86e2026-09-09WarningsExact identifier
unii: 04JA59TNSJ
Vicks DayQuil VapoCOOL SEVERE COLD and FLU plus CONGESTIONACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Companyefb69cc1-a745-6efc-e053-2a95a90abdc92026-09-08WarningsExact identifier
unii: 04JA59TNSJ
Vicks NyQuil VapoCOOL Severe COLD and FLU plus CONGESTIONACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDEThe Procter & Gamble Manufacturing Companyefb5f0b9-9825-ab23-e053-2995a90a26ab2026-09-08WarningsExact identifier
unii: 04JA59TNSJ
Vicks childrens Cough CongestionPHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESINThe Procter & Gamble Manufacturing Companye2356457-9791-3710-e053-2995a90ad1402026-09-08WarningsExact identifier
unii: 04JA59TNSJ
Nighttime Severe Cold and CoughACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINERARITAN PHARMACEUTICALS INC9819155b-2713-42be-867e-16605e7643d02026-09-08WarningsExact identifier
unii: 04JA59TNSJ
Cold and Flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATEWALMART INC.f9d1dfd1-527f-491d-9188-14886ac70ced2026-09-08WarningsExact identifier
unii: V1Q0O9OJ9Z
severe cold and cough daytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDERARITAN PHARMACEUTICALS INC3ce8508e-7d9d-4413-858a-8f952e760c012026-09-08WarningsExact identifier
unii: 04JA59TNSJ
Multi Symptom Severe ColdACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLRARITAN PHARMACEUTICALS INCd9606c9a-31b1-4121-9870-809a05f5b68a2026-09-08WarningsExact identifier
unii: 04JA59TNSJ

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.