FDA.reportPublic FDA data

Calamine

Product NDC
49035-413
11-digit product format
490350413
Labeler code
49035
Product ID
49035-413_52b88341-bb0b-9bfa-e063-6394a90ad9bf
Type
HUMAN OTC DRUG
Nonproprietary name
Calamine and Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Wal-Mart Stores, Inc.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-12-30
Substance
ZINC OXIDE
Active strength
160 mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
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
Calamine
Listing expiration
2027-12-31

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
61929c97-bd6b-0d7c-e053-2991aa0aa571Available 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
49035-413-96Calamine177 mL in 1 BOTTLE, PLASTICLOTION1779

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-413-96ML - Milliliter49035-4137e7b875e-2bf4-446d-b431-a6e21148f17112023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-413CALAMINE (CALAMINE AND ZINC OXIDE) LOTION [WAL-MART STORES, INC.]8Current NDC, Legacy NDC, 1 package rows20231220_61929c97-bd6b-0d7c-e053-2991aa0aa571.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 8 of 70 · 1,384 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zinc Oxide 20%ZINC OXIDETrifecta Pharmaceuticals USA8cbe9b1f-fec0-9579-e053-2995a90ac4612026-06-22WarningsExact identifier
application number: M016
Petroleum Skin ProtectantWHITE PETROLATUMWalmart Inc.e294a871-ae73-4a4f-89a3-9ebf0b4fd03a2026-06-19Warnings, Adverse reactionsExact identifier
application number: M016
Diaper Rash CreamZINC OXIDEFoshan Desha Biotechnology Co., Ltd.5487ad62-3d73-042e-e063-6394a90afe8c2026-06-18WarningsExact identifier
application number: M016
Baby HealingOintmentPETROLATUMFoshan Desha Biotechnology Co., Ltd.5488b81a-e5fe-1452-e063-6394a90a2ae42026-06-18WarningsExact identifier
application number: M016
Baby Eczema Moisturizing CreamCOLLOIDAL OATMEALFoshan Desha Biotechnology Co., Ltd.548a0c34-6aac-14f7-e063-6394a90ae6522026-06-18WarningsExact identifier
application number: M016
Jell with Vitamin A DLANOLIN, PETROLATUMJell Pharmaceuticals Pvt Ltd.d976e5f0-1be5-d9c4-e053-2a95a90a44a42026-06-17WarningsExact identifier
application number: M016
DoveANTIBACTERIAL CARE BEAUTY BARConopco d/b/a Unilever547472cf-4902-584e-e063-6294a90a28ac2026-06-17WarningsExact identifier
application number: M016
Dr Sosnowskis Chafing Hero Severe Chafing BalmLANOLINHerstat (USA) Inc.389041a8-7316-b38e-e063-6294a90a3e8e2026-06-17WarningsExact identifier
application number: M016
Drs. Pharmacy Creamy Cocoa Butter Petroleum JellyWHITE PETROLATUMOL PHARMA TECH, LLC Drs PHARMACY546749e3-70c5-10e8-e063-6294a90ad8c42026-06-16WarningsExact identifier
application number: M016
Drs. Pharmacy Creamy Petroleum JellyWHITE PETROLATUMOL PHARMA TECH, LLC Drs PHARMACY54698388-f9e8-c470-e063-6394a90a783b2026-06-16WarningsExact identifier
application number: M016
MedlineZINC OXIDEMedline Industries, LP3c319953-04fc-87a8-e063-6294a90a50582026-06-15WarningsExact identifier
application number: M016
Calamine, Pramoxind HClCALAMINE, PRAMOXIND HCLH E B4a7a0b09-d9bc-e752-e063-6394a90a9f2c2026-06-15Warnings, Adverse reactionsExact identifier
application number: M016
Calamine, Zinc OxideCALAMINE, ZINC OXIDEH E B4a79259e-64ac-d187-e063-6294a90a78db2026-06-15Warnings, Adverse reactionsExact identifier
application number: M016
HEALMUSZ HEALTHY FEETUREA 40% SALICYLIC ACID 2% GREEN TEA LEAFL 1% COCONUT OIL 1% HEALTHY FEETJiangxi Yudexi Pharmaceutical Co., LTD4a34b6de-03ec-3be4-e063-6294a90afb522026-06-14WarningsExact identifier
application number: M016
PUVIDA SNOW BLEACHNIACINAMIDE 15% SNOW BLEACHJiangxi Yudexi Pharmaceutical Co., LTD4a48ebbd-7c80-1bce-e063-6294a90ab4ae2026-06-14WarningsExact identifier
application number: M016
XIMONTH Foot Shoe DeodorizerGLYCERINShantou Ximonth Biotechnology Co., Ltd.541d9ce9-62ad-847e-e063-6394a90a55e02026-06-13WarningsExact identifier
application number: M016
Skin Protectant with 33% Petrolatum Advance Moisturizing CreamPETROLATUMAldermed Inc.87413149-d39f-4f8a-b1c9-6de5eb37ff7e2026-06-12WarningsExact identifier
application number: M016
Zinc Oxide 20%ZINC OXIDE, WHITE PETROLATUMAldermed Inc.54154a72-27ad-7bfa-e063-6394a90a4eca2026-06-12WarningsExact identifier
application number: M016
Circletong Tag Wart Remover PatchesGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.541b0fe9-f900-8191-e063-6394a90af3212026-06-12WarningsExact identifier
application number: M016
Baby ButzZINC OXIDEOlen Skin Care Corporatione6be6b62-13a4-410d-b8ac-457b58fd23da2026-06-10WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617954calamine 8 % / zinc oxide 8 % Topical LotionPSN61929c97-bd6b-0d7c-e053-2991aa0aa5719
617954calamine 80 MG/ML / zinc oxide 80 MG/ML Topical LotionSCD61929c97-bd6b-0d7c-e053-2991aa0aa5719
617954calamine 8 % / zinc oxide 8 % Topical LotionSY61929c97-bd6b-0d7c-e053-2991aa0aa5719
617954Calamine 80 MG/ML / ZNO 80 MG/ML Topical LotionSY61929c97-bd6b-0d7c-e053-2991aa0aa5719

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-413-9649035041396177 mL in 1 BOTTLE, PLASTIC (49035-413-96) 177 ml2017-12-300000-00-00NoNoCurrent