FDA.reportPublic FDA data

Caldyphen Clear

Product NDC
24385-439
11-digit product format
243850439
Labeler code
24385
Product ID
24385-439_a89b2e0e-3553-6b1a-e053-2995a90a1a17
Type
HUMAN OTC DRUG
Nonproprietary name
Pramoxine Hydrochloride and Zinc acetate
Dosage form
LOTION
Route
TOPICAL
Labeler
Amerisource Bergen
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2008-01-01
Marketing end
0000-00-00
Substance
PRAMOXINE HYDROCHLORIDE; ZINC ACETATE
Active strength
10 mg/mL; mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC]; Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

Additional Listing Data#

Finished product
Yes
Brand name base
Caldyphen Clear

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAMOXINE HYDROCHLORIDE10 mg/mL
ZINC ACETATE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii88AYB867L5, FM5526K07A
Rxcui1234546

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
24385-439-302022-07-29C16284748780-19d75b9d0-c229-f424-e053-dadaa90a57ceCaldyphen Clear
24385-439-302020-03-18C16284748780-19d75b9d0-c229-f424-e053-dadaa90a57ceCaldyphen Clear
24385-439-302020-01-31C16284748780-19d75b9d0-c229-f424-e053-dadaa90a57ceCaldyphen Clear

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24385-439-30Caldyphen Clear177 mL in 1 BOTTLE, PLASTICLOTION1774

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24385-439-30ML - Milliliter24385-43991af2a34-0e06-412d-945e-e515b9815f8a12013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L5CALDYPHEN CLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [AMERISOURCE BERGEN]1
ZINC ACETATEACTIVE INGREDIENTFM5526K07ACALDYPHEN CLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [AMERISOURCE BERGEN]1
PRAMOXINEACTIVE MOIETY068X84E056CALDYPHEN CLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [AMERISOURCE BERGEN]1
ZINC CATIONACTIVE MOIETY13S1S8SF37CALDYPHEN CLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [AMERISOURCE BERGEN]1
CAMPHOR (NATURAL)INACTIVE INGREDIENTN20HL7Q941CALDYPHEN CLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [AMERISOURCE BERGEN]1
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4CALDYPHEN CLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [AMERISOURCE BERGEN]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCALDYPHEN CLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [AMERISOURCE BERGEN]1
HYDROXYPROPYL METHYLCELLULOSE E5 [II]INACTIVE INGREDIENTR75537T0T4CALDYPHEN CLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [AMERISOURCE BERGEN]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCALDYPHEN CLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [AMERISOURCE BERGEN]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCALDYPHEN CLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [AMERISOURCE BERGEN]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CALDYPHEN CLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [AMERISOURCE BERGEN]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCALDYPHEN CLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [AMERISOURCE BERGEN]1
WATERINACTIVE INGREDIENT059QF0KO0RCALDYPHEN CLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [AMERISOURCE BERGEN]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24385-439CALDYPHEN CLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [AMERISOURCE BERGEN]3Legacy NDC, 1 package rows20200622_d8802e56-649e-4494-86ee-7ca8841cc28b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234546pramoxine HCl 1 % / zinc acetate 0.1 % Topical LotionPSNd8802e56-649e-4494-86ee-7ca8841cc28b4
1234546pramoxine hydrochloride 10 MG/ML / zinc acetate 1 MG/ML Topical LotionSCDd8802e56-649e-4494-86ee-7ca8841cc28b4
1234546pramoxine HCl 1 % / zinc acetate 0.1 % Topical LotionSYd8802e56-649e-4494-86ee-7ca8841cc28b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24385-439-3024385043930177 mL in 1 BOTTLE, PLASTIC (24385-439-30) 177 ml2013-06-280000-00-00NoNoCurrent