FDA.reportPublic FDA data

Cold Medicine

Product NDC
63654-605
11-digit product format
636540605
Labeler code
63654
Product ID
63654-605_24b20246-5fa0-1d44-e063-6394a90a625d
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Selder, S.A. de C.V.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-06-27
Substance
ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 2; 5 mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cold Medicine
Brand name suffix
XL3
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
CHLORPHENIRAMINE MALEATE2 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, V1Q0O9OJ9Z, 04JA59TNSJ
Rxcui1046781

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
63654-605-20Cold MedicineXL310 in 1 BLISTER PACKTABLET102
63654-605-20Cold MedicineXL32 in 1 BOXTABLET22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63654-605COLD MEDICINE XL3 (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE) TABLET [SELDER, S.A. DE C.V.]2Current NDC, Legacy NDC, 2 package rows20241027_e2c35fae-9dd6-51f2-e053-2995a90a1e9e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046781acetaminophen 325 MG / chlorpheniramine maleate 2 MG / phenylephrine HCl 5 MG Oral TabletPSNe2c35fae-9dd6-51f2-e053-2995a90a1e9e2
1046781acetaminophen 325 MG / chlorpheniramine maleate 2 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDe2c35fae-9dd6-51f2-e053-2995a90a1e9e2
1046781APAP 325 MG / chlorpheniramine maleate 2 MG / phenylephrine hydrochloride 5 MG Oral TabletSYe2c35fae-9dd6-51f2-e053-2995a90a1e9e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63654-605-20636540605202 BLISTER PACK in 1 BOX (63654-605-20) / 10 TABLET in 1 BLISTER PACK2 blister pack2022-06-270000-00-00NoNoCurrent