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 6 of 234 · 4,671 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sinus PE Head Congestion and MucusACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLBetter Living Brands, LLC28a4ec37-11dd-4134-81aa-851f081bf0882026-08-17WarningsExact identifier
unii: 04JA59TNSJ
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCardinal Health 110, LLC. DBA Leader610accad-2f8b-4605-9357-a58e6e18d4172026-08-15WarningsExact identifier
unii: 04JA59TNSJ
CVS NightTime ColdACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDECVS PHARMACY0f0cc40d-7939-4d4d-a931-b4de4070fea12026-08-14WarningsExact identifier
unii: 04JA59TNSJ
BM BM134 DROPSARSENIC ALBUM, HYDRASTIS, MYRISTICA, NITRIC ACID, PAEONIA, RHUS TOX, SILICEABM Private Limited59023500-89be-cc76-e063-6294a90a6e022026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM173 DROPSECHINACEA, EUPHRASIA, NATRUM MUR, RHUS TOX, SILICEA, SULPHUR, URTICA URENBM Private Limited59036ca4-e7bb-bbe7-e063-6394a90a410a2026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4
CHILDRENS DIMETAPP COLD AND COUGHBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCVS PHARMACY7babf4f6-ca0a-44a7-b1ea-d60e20d36f152026-08-14WarningsExact identifier
unii: 04JA59TNSJ
Theraflu Relief Max Strength NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND DEXTROMETHOPHAN HBRCVS PHARMACY4b567234-1da9-4e10-a427-877eea2be1c12026-08-14WarningsExact identifier
unii: V1Q0O9OJ9Z
CVS Severe Multi-Symptom Cough Cold FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS PHARMACYbb24c298-1d00-4378-8de3-b4056220fa752026-08-14WarningsExact identifier
unii: 04JA59TNSJ
CVS Childrens Cold and AllergyBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCLCVS PHARMACY, INC.f4020c08-29f6-4609-834e-191ce68851302026-08-14WarningsExact identifier
unii: 04JA59TNSJ
Daytime Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCVS PHARMACY81d26e9c-b713-4fb3-b0a5-68526bad230e2026-08-14WarningsExact identifier
unii: 04JA59TNSJ
nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLAmazon.com Services LLC212acd54-6ff0-446a-a3bb-3b40e12797112026-08-13WarningsExact identifier
unii: 04JA59TNSJ
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAmazon.com Services LLC1e3c81b0-05de-4c4a-8579-f301f14626b32026-08-13WarningsExact identifier
unii: 04JA59TNSJ
Treatonic hemorrhoid treatment5% LIDOCAINE100 KARMA INC41442fa7-c511-07ca-e063-6294a90a39922026-08-12WarningsExact identifier
unii: 04JA59TNSJ
Naproxen SodiumNAPROXEN SODIUMHarris Teeter27938b08-ff37-4587-aa81-5ec3ef21a28a2026-08-12WarningsExact identifier
rxcui: 849574
unii: 9TN87S3A3C
Naproxen SodiumNAPROXEN SODIUMHarris Teeter38543976-ccbe-4af9-b01d-ae102452d4182026-08-12WarningsExact identifier
rxcui: 849574
unii: 9TN87S3A3C
Cold and Flu DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)af35c833-316a-4d21-bd3a-9b71558cadbf2026-08-12WarningsExact identifier
unii: 04JA59TNSJ
AdaptopathADENOSINUM CYCLOPHOSPHORICUM, ALPHA-LIPOICUM ACIDUM, ARGENTUM METALLICUM, AVENA SATIVA, CAPSICUM ANNUUM, CITRICUM ACIDUM, COENZYME A, CUPRUM METALLICUM, GINKGO BILOBA, GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HYPOTHALAMUS (BOVINE), IODIUM, LEDUM PALUSTRE, MANGANUM ACETICUM, NADIDUM, NATRUM CARBONICUM, OLEUM MORRHUAE, PHOSPHORICUM ACIDUM, PICRICUM ACIDUM, RIBOFLAVINUM, SELENIUM METALLICUM SEPIA, SILICEA, THIAMINUM HYDROCHLORICUM, THYROIDINUM (BOVINE), VANADIUM METALLICUMEnergetix Corporation41234598-0cb5-41c2-bfbe-1c15ee9bf5022026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Agri-ChordARSENICUM ALB, BELLADONNA, CALC CARB, CEANOTHUS, CHELIDONIUM MAJ, CUPRUM SULPH, FUMARICUM AC, GALIUM, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, KALI IOD, LYCOPODIUM, PANCREAS SUIS, PETROLEUM, PHOSPHORICUM AC, PHOSPHORUS, PHYTOLACCA, SARSAPARILLA, SILICEA, SULPHUR, THYROIDINUM, TRIFOLIUM PRAT, XANTHOXYLUM, ZINC PHOSEnergetix Corporation9eb50e9a-3528-4809-bd76-47d99ef03f0e2026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Drainage-ToneCALCAREA IODATA, CAPSICUM ANNUUM, COENZYME A, ECHINACEA ANGUSTIFOLIA, EQUISETUM ARVENSE, HYDRASTIS CANADENSIS, NADIDUM, NITRICUM ACIDUM, OLEUM MORRHUAE, PETROSELINUM SATIVUM, PHYTOLACCA DECANDRA, SCROPHULARIA NODOSA, SILICEA, SINAPIS ALBA, THUJA OCCIDENTALIS.Energetix Corporation296b455e-27c5-4f6e-929d-c4ee75b7fb0e2026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
HypothalmapathGELSEMIUM, GINKGO, GLYCYRRHIZA, HYDROCOTYLE, HYPOTHALAMUS, PETROSELINUM, PITUITARUM POSTERIUM, PYRIDOXINUM HYDROCHLORICUM, SENNA, SILICEAEnergetix Corporation3c4e2867-4d75-416b-9f3d-e6e500e46f6f2026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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