FDA.reportPublic FDA data

Defensol D

Product NDC
53145-005
11-digit product format
531450005
Labeler code
53145
Product ID
53145-005_3a88bd55-586f-64c5-e063-6394a90a6788
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Chlorpherinamine maleate, Phenylephrine HCI
Dosage form
TABLET
Route
ORAL
Labeler
Menper Distributors, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-02-21
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
Defensol D
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53145-005-022020-01-31C16284748780-19d75b9d0-3370-f424-e053-dadaa90a57ceDefensol D
53145-005-302020-01-31C16284748780-19d75b9d0-3370-f424-e053-dadaa90a57ceDefensol D

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53145-005-02Defensol D50 in 1 CARTONTABLET505
53145-005-02Defensol D2 in 1 PACKAGETABLET25
53145-005-30Defensol D30 in 1 BOTTLETABLET305
53145-005-30Defensol D1 in 1 BOXTABLET15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DDEFENSOL D (ACETAMINOPHEN, CHLORPHERINAMINE MALEATE, PHENYLEPHRINE HCI) TABLET [MENPER DISTRIBUTORS, INC.]1
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZDEFENSOL D (ACETAMINOPHEN, CHLORPHERINAMINE MALEATE, PHENYLEPHRINE HCI) TABLET [MENPER DISTRIBUTORS, INC.]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJDEFENSOL D (ACETAMINOPHEN, CHLORPHERINAMINE MALEATE, PHENYLEPHRINE HCI) TABLET [MENPER DISTRIBUTORS, INC.]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DDEFENSOL D (ACETAMINOPHEN, CHLORPHERINAMINE MALEATE, PHENYLEPHRINE HCI) TABLET [MENPER DISTRIBUTORS, INC.]1
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965UDEFENSOL D (ACETAMINOPHEN, CHLORPHERINAMINE MALEATE, PHENYLEPHRINE HCI) TABLET [MENPER DISTRIBUTORS, INC.]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVDEFENSOL D (ACETAMINOPHEN, CHLORPHERINAMINE MALEATE, PHENYLEPHRINE HCI) TABLET [MENPER DISTRIBUTORS, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDEFENSOL D (ACETAMINOPHEN, CHLORPHERINAMINE MALEATE, PHENYLEPHRINE HCI) TABLET [MENPER DISTRIBUTORS, INC.]1
HYPROMELLOSE 2208 (100 MPA.S)INACTIVE INGREDIENTB1QE5P712KDEFENSOL D (ACETAMINOPHEN, CHLORPHERINAMINE MALEATE, PHENYLEPHRINE HCI) TABLET [MENPER DISTRIBUTORS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DEFENSOL D (ACETAMINOPHEN, CHLORPHERINAMINE MALEATE, PHENYLEPHRINE HCI) TABLET [MENPER DISTRIBUTORS, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EDEFENSOL D (ACETAMINOPHEN, CHLORPHERINAMINE MALEATE, PHENYLEPHRINE HCI) TABLET [MENPER DISTRIBUTORS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DEFENSOL D (ACETAMINOPHEN, CHLORPHERINAMINE MALEATE, PHENYLEPHRINE HCI) TABLET [MENPER DISTRIBUTORS, INC.]1
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJDEFENSOL D (ACETAMINOPHEN, CHLORPHERINAMINE MALEATE, PHENYLEPHRINE HCI) TABLET [MENPER DISTRIBUTORS, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDEFENSOL D (ACETAMINOPHEN, CHLORPHERINAMINE MALEATE, PHENYLEPHRINE HCI) TABLET [MENPER DISTRIBUTORS, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDEFENSOL D (ACETAMINOPHEN, CHLORPHERINAMINE MALEATE, PHENYLEPHRINE HCI) TABLET [MENPER DISTRIBUTORS, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046781acetaminophen 325 MG / chlorpheniramine maleate 2 MG / phenylephrine HCl 5 MG Oral TabletPSNf466c660-69eb-4581-81ff-1499fa421d8b5
1046781acetaminophen 325 MG / chlorpheniramine maleate 2 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDf466c660-69eb-4581-81ff-1499fa421d8b5
1046781APAP 325 MG / chlorpheniramine maleate 2 MG / phenylephrine hydrochloride 5 MG Oral TabletSYf466c660-69eb-4581-81ff-1499fa421d8b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53145-005-025314500050250 PACKAGE in 1 CARTON (53145-005-02) / 2 TABLET in 1 PACKAGE50 package2012-02-21NoNoHistorical
53145-005-30531450005301 BOTTLE in 1 BOX (53145-005-30) / 30 TABLET in 1 BOTTLE1 bottle2012-02-21NoNoHistorical