Cold Medicine

Product NDC
63654-600
11-digit product format
636540600
Labeler code
63654
Product ID
63654-600_09cc48f3-e043-4da8-a9f1-00cb6ccbee95
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Selder, S.A. de C.V.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-11-15
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325 mg/1; mg/1; mg/1
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63654-600-022019-11-13C16284748780-197449f38-c6d7-f6ea-e053-dbdaa90aa703Drug Facts
63654-600-682019-11-13C16284748780-197449f38-c6d7-f6ea-e053-dbdaa90aa703Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63654-600-02Cold MedicineXL325 in 1 BLISTER PACKTABLET251
63654-600-68Cold MedicineXL320 in 1 BLISTER PACKTABLET201

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DCOLD MEDICINE XL3 (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE ) TABLET [SELDER, S.A. DE C.V.]1
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZCOLD MEDICINE XL3 (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE ) TABLET [SELDER, S.A. DE C.V.]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJCOLD MEDICINE XL3 (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE ) TABLET [SELDER, S.A. DE C.V.]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DCOLD MEDICINE XL3 (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE ) TABLET [SELDER, S.A. DE C.V.]1
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965UCOLD MEDICINE XL3 (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE ) TABLET [SELDER, S.A. DE C.V.]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVCOLD MEDICINE XL3 (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE ) TABLET [SELDER, S.A. DE C.V.]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MCOLD MEDICINE XL3 (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE ) TABLET [SELDER, S.A. DE C.V.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCOLD MEDICINE XL3 (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE ) TABLET [SELDER, S.A. DE C.V.]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GCOLD MEDICINE XL3 (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE ) TABLET [SELDER, S.A. DE C.V.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACOLD MEDICINE XL3 (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE ) TABLET [SELDER, S.A. DE C.V.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ECOLD MEDICINE XL3 (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE ) TABLET [SELDER, S.A. DE C.V.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCOLD MEDICINE XL3 (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE ) TABLET [SELDER, S.A. DE C.V.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCOLD MEDICINE XL3 (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE ) TABLET [SELDER, S.A. DE C.V.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63654-600COLD MEDICINE XL3 (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE ) TABLET [SELDER, S.A. DE C.V.]1Legacy NDC, 2 package rows20111115_fc4d100b-eaa9-4e46-a27a-74094aa11d0f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1193293acetaminophen 325 MG / chlorpheniramine maleate 4 MG / phenylephrine HCl 10 MG Oral TabletPSNfc4d100b-eaa9-4e46-a27a-74094aa11d0f1
1193293acetaminophen 325 MG / chlorpheniramine maleate 4 MG / phenylephrine hydrochloride 10 MG Oral TabletSCDfc4d100b-eaa9-4e46-a27a-74094aa11d0f1
1193293APAP 325 MG / chlorpheniramine maleate 4 MG / phenylephrine hydrochloride 10 MG Oral TabletSYfc4d100b-eaa9-4e46-a27a-74094aa11d0f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
63654-600-026365406000225 in 1 BLISTER PACKHistorical
63654-600-686365406006820 in 1 BLISTER PACKHistorical