FDA.reportPublic FDA data

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 11 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daily MoisturizingDIMETHICONEAldi, Inc118a1a07-7283-4353-97b5-6ac3b1cc14302026-05-08Warnings, Adverse reactionsExact identifier
application number: M016
DoveANTIBACTERIAL CARE MOISTURIZING CREAMConopco Inc. d/b/a/ Unilever5150f48c-ff0c-ce39-e063-6394a90ad4242026-05-08WarningsExact identifier
application number: M016
Seedlings Diaper Rash CreamZINC OXIDEYoung Living Essential Oils, LC.4d8aeaba-ddb1-6f74-e054-00144ff88e882026-05-08WarningsExact identifier
application number: M016
Nail Repairs PatchesGLYCERINShantou Ximonth Biotechnology Co., Ltd.5120b708-047a-1182-e063-6394a90a74c32026-05-06WarningsExact identifier
application number: M016
AOAO Acne Buster Salicylic Acid Drying SerumZINC OXIDE,NIACINAMIDE,COLLOIDAL SULFUR,AZELAIC ACID,SALICYLIC ACID.Guangzhou Senmai Biotechnology Co.,Ltd.512185a5-5c1d-ef9f-e063-6394a90a81af2026-05-06WarningsExact identifier
application number: M016
AKOLKOL TOENAIL FUNGUS TREATMENTGLYCERINShantou Ximonth Biotechnology Co., Ltd.5121c341-e5e9-2b36-e063-6394a90a93b82026-05-06WarningsExact identifier
application number: M016
Beyond Good Diaper RashZINC OXIDEBabylist, Inc512b62df-4f08-d839-e063-6294a90ab52f2026-05-06WarningsExact identifier
application number: M016
Acne Buster Salicylic Acid Drying SerumZINC OXIDE,NIACINAMIDE,COLLOIDAL SULFUR,AZELAIC ACID,SALICYLIC ACID.Guangzhou Senmai Biotechnology Co.,Ltd.4c531280-bc5b-1cf2-e063-6394a90a034a2026-05-05WarningsExact identifier
application number: M016
PEGO Acne Buster Salicylic Acid Drying SerumZINC OXIDE,NIACINAMIDE,COLLOIDAL SULFUR,AZELAIC ACID,SALICYLIC ACID.Guangzhou Senmai Biotechnology Co.,Ltd.511eaced-c4d8-ae94-e063-6394a90a320e2026-05-05WarningsExact identifier
application number: M016
Rugby Gas reliefSIMETHICONERugby Laboratories9b84f74f-8609-489d-b411-3103afa1b5c22026-05-04WarningsExact identifier
application number: M016
Vitamin A and DPETROLATUMAldermed Inc.3f13a15c-8b64-48f0-a459-853b9097bc312026-05-04WarningsExact identifier
application number: M016
Zinc Oxide Skin ProtectantZINC OXIDE 20%Aldermed Inc.a55ac5b4-bac7-4d2a-8ac8-c3eaf7e89e522026-05-04WarningsExact identifier
application number: M016
Petroleum JellyWHITE PETROLATUMAldermed Inc.4e02af41-db86-46d8-a97d-332d84eced6f2026-05-04WarningsExact identifier
application number: M016
Daily MoisturizerLOTIONWalgreensfc65f673-b23d-1ffa-e053-6394a90a09662026-05-03WarningsExact identifier
application number: M016
Dry Skin HealingPETROLATUMWalgreen0397507d-4b6e-c679-e063-6294a90a0b332026-05-03WarningsExact identifier
application number: M016
Daily MoisturizerLOTIONWalgreenfc67037a-ed31-f678-e053-6394a90a71752026-05-03WarningsExact identifier
application number: M016
Skin ReliefLOTIONWalgreenfc678e80-e63d-e3fe-e053-6394a90aa7d62026-05-03WarningsExact identifier
application number: M016
Petroleum JellyWHITE PETROLATUMWalmart INCf76ceecc-ef11-3839-e053-6394a90a8d4a2026-05-03WarningsExact identifier
application number: M016
Herpecin LDIMETHICONE AND MERADIMATE AND OCTINOXATE AND OCTISALATE AND OXYBENZONEFocus Consumer Healthcare, LLC5b6ed4e9-3e69-c773-e053-2991aa0a7dfe2026-05-01WarningsExact identifier
application number: M016
CalamineFERRIC OXIDE REDRetail Business Services, LLC7291e175-a9b6-4c47-93ce-227ce11e45992026-04-30Warnings, Adverse reactionsExact 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