GNP Caldyphen

Product NDC
24385-072
11-digit product format
243850072
Labeler code
24385
Product ID
24385-072_537410b5-4125-c34f-e063-6394a90aad35
Type
HUMAN OTC DRUG
Nonproprietary name
Calamine and Pramoxine Hydrochloride
Dosage form
LOTION
Route
TOPICAL
Labeler
Amerisource Bergen
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-01-01
Marketing end
2027-03-01
Substance
ZINC OXIDE; PRAMOXINE HYDROCHLORIDE
Active strength
80; 10 mg/mL; mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
GNP Caldyphen

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE80 mg/mL
PRAMOXINE HYDROCHLORIDE10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
88AYB867L5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1234532Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
515c58d7-0dc4-45e7-9155-e5270a16290eAvailable on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24385-072-82GNP Caldyphen177 mL in 1 BOTTLE, PLASTICLOTION1775

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24385-072-82ML - Milliliter24385-0728f13e508-d05e-4100-8b8a-4ad1b4f9f64712013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L5GNP CALDYPHEN (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [AMERISOURCE BERGEN]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZGNP CALDYPHEN (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [AMERISOURCE BERGEN]1
PRAMOXINEACTIVE MOIETY068X84E056GNP CALDYPHEN (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [AMERISOURCE BERGEN]1
ZINC CATIONACTIVE MOIETY13S1S8SF37GNP CALDYPHEN (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [AMERISOURCE BERGEN]1
CAMPHOR (NATURAL)INACTIVE INGREDIENTN20HL7Q941GNP CALDYPHEN (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [AMERISOURCE BERGEN]1
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4GNP CALDYPHEN (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [AMERISOURCE BERGEN]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXGNP CALDYPHEN (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [AMERISOURCE BERGEN]1
HYDROXYPROPYL METHYLCELLULOSE E5 [II]INACTIVE INGREDIENTR75537T0T4GNP CALDYPHEN (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [AMERISOURCE BERGEN]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TGNP CALDYPHEN (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [AMERISOURCE BERGEN]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGNP CALDYPHEN (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [AMERISOURCE BERGEN]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GNP CALDYPHEN (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [AMERISOURCE BERGEN]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHGNP CALDYPHEN (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [AMERISOURCE BERGEN]1
WATERINACTIVE INGREDIENT059QF0KO0RGNP CALDYPHEN (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [AMERISOURCE BERGEN]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24385-072GNP CALDYPHEN (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [AMERISOURCE BERGEN]5Current NDC, Legacy NDC, 1 package rows20231215_515c58d7-0dc4-45e7-9155-e5270a16290e.zip

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 14 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ChapStick Classic Variety-Classic Cherry-Classic Strawberry-Classic SpearmintSKIN PROTECTANT LIP BALMSuave Brands Co., LLC4523af69-1a0d-6d18-e063-6394a90ad9d12026-03-30WarningsExact identifier
application number: M016
ChapStick Sweet Valetine Berry Much Besties, Mint To Be, Cherish Me CherryLIP BALM SKIN PROTECTANTSuave Brands Company47a2487d-b2e5-7195-e063-6394a90ae4812026-03-30WarningsExact identifier
application number: M016
ChapStick Classic CherrySKIN PROTECTANT LIP BALMSuave Brands Co., LLC4512b5a0-ce1f-c53e-e063-6294a90a56b62026-03-30WarningsExact identifier
application number: M016
ChapStick Classic StrawberrySKIN PROTECTANT LIP BALMSuave Brands Co., LLC42770fff-d70a-d9d1-e063-6294a90aa98d2026-03-30WarningsExact identifier
application number: M016
Aveeno Skin Relief HealingGLYCERINKenvue Brands LLC345fdde5-700b-7103-e063-6394a90a0e3e2026-03-27WarningsExact identifier
application number: M016
Critic Aid ClearPETROLATUMColoplast Corp0b6da97e-519b-4579-9895-f4ede5c48b472026-03-27WarningsExact identifier
application number: M016
Baza ProtectZINC OXIDE AND DIMETHICONEColoplast Corp256dfcfc-a91c-49b0-9439-452586a0880e2026-03-27WarningsExact identifier
application number: M016
Sween 24DIMETHICONEColoplast Corpa623c8d7-8db0-410a-9980-02ac02f7b6ea2026-03-27WarningsExact identifier
application number: M016
Baza Cleanse and Protect Odor ControlDIMETHICONEColoplast Corpca5fa4ae-c18d-4457-b520-4a9318ea821f2026-03-27WarningsExact identifier
application number: M016
Baza Cleanse and ProtectDIMETHICONEColoplast Corp82eff041-0c9d-4261-a6b6-5a041a6600742026-03-27WarningsExact identifier
application number: M016
Baza ClearPETROLATUMColoplast Corp69d9f456-1a35-4146-8366-c0285648a1722026-03-27WarningsExact identifier
application number: M016
Vitamin A DLANOLIN, PETROLATUMTopco Associates LLC5126fdf6-5df5-474b-bc0d-3a82dea61abb2026-03-26Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMAmazon.com Services LLCcdf1bd12-ac59-4f06-be0f-ef6eb3caeeff2026-03-26Warnings, Adverse reactionsExact identifier
application number: M016
Dynashield with DimethiconeZINC OXIDEDynarex Corporationb5dcf9e8-4689-4a08-ae73-3a859b4cbffe2026-03-26WarningsExact identifier
application number: M016
Eczema Relief CreamCOLLOIDAL OATMEALLavior Pharma Incbdd2fc9f-2718-1d88-e053-2995a90a86822026-03-26WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC36f2dec8-7ffc-fc3e-e063-6294a90a76ff2026-03-26WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC36f33001-7fec-682e-e063-6394a90a94282026-03-26WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC36f3b300-f32f-8881-e063-6394a90a1a2a2026-03-26WarningsExact identifier
application number: M016
White PetrolatumPETROLATUMDynarex Corporation81f5092d-0632-bf47-e053-2991aa0ac5632026-03-25WarningsExact identifier
application number: M016
MYEVERESTRIOL CREAMHubei Redrui Building Materials Co., Ltd.3ed85485-a441-4c05-e063-6394a90afef52026-03-25WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234532calamine 8 % / pramoxine HCl 1 % Topical LotionPSN515c58d7-0dc4-45e7-9155-e5270a16290e5
1234532calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical LotionSCD515c58d7-0dc4-45e7-9155-e5270a16290e5
1234532calamine 8 % / pramoxine hydrochloride 1 % Topical LotionSY515c58d7-0dc4-45e7-9155-e5270a16290e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24385-072-8224385007282177 mL in 1 BOTTLE, PLASTIC (24385-072-82) 177 ml2013-06-282027-03-01NoNoCurrent