FDA.reportPublic FDA data

GNP Calamine Topical Suspension

Product NDC
24385-413
11-digit product format
243850413
Labeler code
24385
Product ID
24385-413_53740c50-0f6a-f5ea-e063-6294a90a48ea
Type
HUMAN OTC DRUG
Nonproprietary name
Calamine 8% and Zinc Oxide 8%
Dosage form
LOTION
Route
TOPICAL
Labeler
Amerisource Bergen
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-01-01
Marketing end
2029-11-01
Substance
ZINC OXIDE
Active strength
160 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 Calamine Topical Suspension

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE160 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
617954Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
777b0e66-1bce-4483-9dad-c46796fd6f23Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24385-413-96GNP Calamine Topical Suspension177 mL in 1 BOTTLE, PLASTICLOTION1775

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24385-413-96ML - Milliliter24385-4139477c0b9-62d7-4cf7-8602-b1fb4ff448f912013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZGNP CALAMINE TOPICAL SUSPENSION (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [AMERISOURCE BERGEN]1
ZINC CATIONACTIVE MOIETY13S1S8SF37GNP CALAMINE TOPICAL SUSPENSION (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [AMERISOURCE BERGEN]1
BENTONITEINACTIVE INGREDIENTA3N5ZCN45CGNP CALAMINE TOPICAL SUSPENSION (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [AMERISOURCE BERGEN]1
CALCIUM HYDRIDEINACTIVE INGREDIENTWY779SQ0XWGNP CALAMINE TOPICAL SUSPENSION (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [AMERISOURCE BERGEN]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXGNP CALAMINE TOPICAL SUSPENSION (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [AMERISOURCE BERGEN]1
WATERINACTIVE INGREDIENT059QF0KO0RGNP CALAMINE TOPICAL SUSPENSION (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [AMERISOURCE BERGEN]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24385-413GNP CALAMINE TOPICAL SUSPENSION (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [AMERISOURCE BERGEN]5Current NDC, Legacy NDC, 1 package rows20231215_777b0e66-1bce-4483-9dad-c46796fd6f23.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 58 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
insect bite relief 01MENTHOLCosmuses Cosmetics (Ningbo) Co., Ltd.006e457d-bfcd-791a-e063-6294a90a8d662024-09-23WarningsExact identifier
application number: M016
daburZINC OXIDEDabur India Limited22cd1e7a-5448-b3f6-e063-6394a90a880d2024-09-23WarningsExact identifier
application number: M016
DABUR Vitamin A and DWHITE PETROLATUMDabur India Limited22cd44ef-4b02-604d-e063-6394a90a7a0a2024-09-23WarningsExact identifier
application number: M016
DABUR ZINC OXIDE 3.8%ZINC OXIDEDabur India Limited2290bbe2-8a88-b94e-e063-6294a90a7e382024-09-20WarningsExact identifier
application number: M016
Aveeno Baby Daily MoistureDIMETHICONEKenvue Brands LLCb34c8e71-7fad-484c-b387-3c424f50b7432024-09-19WarningsExact identifier
application number: M016
Evereden Intensive Eczema BalmCOLLOIDAL OATMEALEden Brands Inc.2243d4ca-5ca4-54d0-e063-6394a90a39402024-09-16WarningsExact identifier
application number: M016
Whipped GelCOLLOIDAL OATMEALOCEAN OLIVE LLC222b381c-665e-177d-e063-6394a90a33062024-09-15WarningsExact identifier
application number: M016
BioBarrier Renewal CreamALLANTOINbluemercury1ee15f84-0561-3cd2-e063-6394a90ab68e2024-09-15WarningsExact identifier
application number: M016
CalamineCALAMINE AND ZINC OXIDEStrategic Sourcing Services, LLC22173332-9d09-768c-e063-6394a90a94e12024-09-14WarningsExact identifier
application number: M016
Diaper Rash Cream 5.6ozZINC OXIDEChina Ningbo Shangge Cosmetics Technology Corp.21a7c4ce-1360-931c-e063-6294a90aa66d2024-09-11WarningsExact identifier
application number: M016
Healing Cream 3ozPETROLATUMChina Ningbo Shangge Cosmetics Technology Corp.21bdbb13-cc64-b5d7-e063-6294a90ae3fd2024-09-11WarningsExact identifier
application number: M016
Healing Cream15ozPETROLATUMRejoice International Corp.21e4026c-d3da-e4f7-e063-6394a90aabed2024-09-11WarningsExact identifier
application number: M016
Baby Balm Stick 0.65ozPETROLATUM OINTMENTChina Ningbo Shangge Cosmetics Technology Corp.21c0b614-ea19-e98d-e063-6294a90ac44e2024-09-10WarningsExact identifier
application number: M016
Aveeno Skin Relief Moisturizing Fragrance FreeDIMETHICONEKenvue Brands LLC65476a2a-8cd4-4477-ac27-9a06f41e47112024-09-09WarningsExact identifier
application number: M016
Diaper Rash Cream 15ozZINC OXIDERejoice International Corp.213213ab-f935-a62e-e063-6394a90af96b2024-09-03WarningsExact identifier
application number: M016
Diaper Rash Cream 5.6ozZINC OXIDERejoice International Corp.2133876b-eaf0-f988-e063-6394a90aae4d2024-09-03WarningsExact identifier
application number: M016
Baby Balm Stick 0.65ozPETROLATUMRejoice International Corp.20cf3bb8-4ab8-2980-e063-6294a90ad6312024-08-29WarningsExact identifier
application number: M016
SUDOCREM SKIN PROTECTANTZINC OXIDELEDA INNOVATIONS USA, INC.20d2cf0b-d237-fd78-e063-6394a90a8d032024-08-29WarningsExact identifier
application number: M016
Healing Cream 3ozPETROLATUMRejoice International Corp.20c9b964-c9af-d63a-e063-6294a90ab9792024-08-28WarningsExact identifier
application number: M016
Babyganics Soothing ItchOATMEALKAS Direct, LLC5c2806fb-5af4-4532-b31a-be77bb23b2772024-08-28WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617954calamine 8 % / zinc oxide 8 % Topical LotionPSN777b0e66-1bce-4483-9dad-c46796fd6f235
617954calamine 80 MG/ML / zinc oxide 80 MG/ML Topical LotionSCD777b0e66-1bce-4483-9dad-c46796fd6f235
617954calamine 8 % / zinc oxide 8 % Topical LotionSY777b0e66-1bce-4483-9dad-c46796fd6f235
617954Calamine 80 MG/ML / ZNO 80 MG/ML Topical LotionSY777b0e66-1bce-4483-9dad-c46796fd6f235

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24385-413-9624385041396177 mL in 1 BOTTLE, PLASTIC (24385-413-96) 177 ml2017-11-162029-11-01NoNoCurrent