FDA.reportPublic FDA data

Calamine

Product NDC
0904-2533
11-digit product format
009042533
Labeler code
0904
Product ID
0904-2533_4a057dbb-483c-a4b4-e063-6394a90aa36a
Type
HUMAN OTC DRUG
Nonproprietary name
FERRIC OXIDE RED
Dosage form
LOTION
Route
TOPICAL
Labeler
Major Pharmaceuticals
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-01-07
Substance
FERRIC OXIDE RED; ZINC OXIDE
Active strength
80; 80 mg/mL; mg/mL
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
FERRIC OXIDE RED80 mg/mL
ZINC OXIDE80 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1K09F3G675Internal UNII lookup
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
c25be68d-834a-4959-8d47-01ec789406baAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-2533-21Calamine177 mL in 1 BOTTLE, PLASTICLOTION17715

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-2533-21ML - Milliliter0904-2533918d193f-eb73-474a-b375-ecfe47fd756e12014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FERRIC OXIDE REDACTIVE INGREDIENT1K09F3G675CALAMINE (FERRIC OXIDE RED) LOTION [MAJOR PHARMACEUTICALS]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZCALAMINE (FERRIC OXIDE RED) LOTION [MAJOR PHARMACEUTICALS]1
FERRIC OXIDE REDACTIVE MOIETY1K09F3G675CALAMINE (FERRIC OXIDE RED) LOTION [MAJOR PHARMACEUTICALS]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZCALAMINE (FERRIC OXIDE RED) LOTION [MAJOR PHARMACEUTICALS]1
BENTONITEINACTIVE INGREDIENTA3N5ZCN45CCALAMINE (FERRIC OXIDE RED) LOTION [MAJOR PHARMACEUTICALS]1
CALCIUM HYDROXIDEINACTIVE INGREDIENTPF5DZW74VNCALAMINE (FERRIC OXIDE RED) LOTION [MAJOR PHARMACEUTICALS]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCALAMINE (FERRIC OXIDE RED) LOTION [MAJOR PHARMACEUTICALS]1
WATERINACTIVE INGREDIENT059QF0KO0RCALAMINE (FERRIC OXIDE RED) LOTION [MAJOR PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-2533CALAMINE (FERRIC OXIDE RED) LOTION [MAJOR PHARMACEUTICALS]13Current NDC, Legacy NDC, 1 package rows20250412_c25be68d-834a-4959-8d47-01ec789406ba.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 42 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
terrasil Diabetics Ulcer and Sore ReliefALLANTOINAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutionsfd6bf169-f1e2-48d4-b98d-8f3c39981a892025-05-23WarningsExact identifier
application number: M016
Perfect 10 Soothing RecoveryPETROLATUMTopiderm, Inc.e3a4f038-d084-4d77-bd35-13f41856a6152025-04-30WarningsExact identifier
application number: M016
Diabetic Advanced Healing CreamDIMETHICONENeoteric Cosmetics, Inc.46996845-9398-41d8-bf99-79f6a29bec282025-04-30WarningsExact identifier
application number: M016
BabyDiaperCreamBABY DIAPER CREAMWhole Foods Marketd7b19529-d0b2-638b-e053-2a95a90acf2f2025-04-29WarningsExact identifier
application number: M016
ChapIce Moisture SPF 15 Lip BalmOXYBENZONE, OCTINOXATE, PETROLATUMNavajo Manufacturing Company Inc.60ce1a8c-180a-161e-e053-2991aa0ae9812025-04-29WarningsExact identifier
application number: M016
Assurance Barrier CreamDIMETHICONE CREAMWalmart Inc23a2a04f-71ce-4fa1-e063-6394a90a649e2025-04-22WarningsExact identifier
application number: M016
Aveeno Baby Eczema Therapy MoisturizingOATMEALKenvue Brands LLC21d2c0a0-70c3-7fd3-e063-6394a90a46d42025-04-18WarningsExact identifier
application number: M016
Secura Extra ProtectiveZINC OXIDESmith & Nephew Medical Ltd499a1944-1682-4798-9058-3748a5eaa4202025-04-17WarningsExact identifier
application number: M016
Firming Care GelFIRMING CARE GELGuangzhou Jiaan Cosmetics Co.,Ltd.32cb8a71-81cd-cdbd-e063-6394a90ac07f2025-04-15WarningsExact identifier
application number: M016
Baby Mantra Diaper CreamZINC OXIDE 10%Renu Laboratories, LLC0427bbc9-f4c0-0eb6-e063-6294a90a71992025-04-14WarningsExact identifier
application number: M016
Witch HazelWITCH HAZELTOP CARE (Topco Associates LLC)23b592f7-3af3-45ef-897a-fe33ab518b6d2025-04-14WarningsExact identifier
application number: M016
Witch HazelWITCH HAZELStrategic Sourcing Services LLCef3408db-de98-4a43-9215-f80fed14815c2025-04-14WarningsExact identifier
application number: M016
Petroleum JellyPETROLATUMWalgreens69bdd508-7c33-42c5-9a08-e56cf3eaebf32025-04-11WarningsExact identifier
application number: M016
4% 10gTATTOO Numb Cream4% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD322daa32-a74e-1fee-e063-6294a90a37aa2025-04-07WarningsExact identifier
application number: M016
Aluroderm ScarALLANTOINAsclemed USA, Inc.60656ca1-5218-4595-854e-19f1061def1e2025-04-01WarningsExact identifier
application number: M016
Dr. Maxs DiaperZINC OXIDEDr. Maxs LLC31bfa962-5e3b-c5d2-e063-6294a90ac1772025-04-01WarningsExact identifier
application number: M016
VaselineBABY HEALING JELLYConopco Inc. d/b/a Unileverbca3176f-86fe-5969-e053-2995a90a24192025-03-31WarningsExact identifier
application number: M016
4% TATTOO Numb Cream4% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD31646815-f591-c560-e063-6294a90ad11a2025-03-28WarningsExact identifier
application number: M016
Face Saver GelSKIN PROTECTANT GELNeat Feat Products Limited31563dd7-9f58-80f6-e063-6294a90a55712025-03-27WarningsExact identifier
application number: M016
PorphoseCOLLOIDAL OATMEAL TOPICAL SPRAYPorphose315951e0-899f-c968-e063-6294a90abe612025-03-27WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617954calamine 8 % / zinc oxide 8 % Topical LotionPSNc25be68d-834a-4959-8d47-01ec789406ba15
617954calamine 80 MG/ML / zinc oxide 80 MG/ML Topical LotionSCDc25be68d-834a-4959-8d47-01ec789406ba15
617954calamine 8 % / zinc oxide 8 % Topical LotionSYc25be68d-834a-4959-8d47-01ec789406ba15
617954Calamine 80 MG/ML / ZNO 80 MG/ML Topical LotionSYc25be68d-834a-4959-8d47-01ec789406ba15
617954calamine 8 % / zinc oxide 8 % Topical LotionPSN326f3d80-c1bf-4cf0-a662-58e02ed7ee676
617954calamine 80 MG/ML / zinc oxide 80 MG/ML Topical LotionSCD326f3d80-c1bf-4cf0-a662-58e02ed7ee676
617954calamine 8 % / zinc oxide 8 % Topical LotionSY326f3d80-c1bf-4cf0-a662-58e02ed7ee676
617954Calamine 80 MG/ML / ZNO 80 MG/ML Topical LotionSY326f3d80-c1bf-4cf0-a662-58e02ed7ee676
617954calamine 8 % / zinc oxide 8 % Topical LotionPSN66e98554-e158-a519-e053-2a91aa0a67835
617954calamine 80 MG/ML / zinc oxide 80 MG/ML Topical LotionSCD66e98554-e158-a519-e053-2a91aa0a67835
617954calamine 8 % / zinc oxide 8 % Topical LotionSY66e98554-e158-a519-e053-2a91aa0a67835
617954Calamine 80 MG/ML / ZNO 80 MG/ML Topical LotionSY66e98554-e158-a519-e053-2a91aa0a67835

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-2533-2100904253321177 mL in 1 BOTTLE, PLASTIC (0904-2533-21) 177 ml2013-01-070000-00-00NoNoCurrent