FDA.reportPublic FDA data

Calamine

Product NDC
55319-063
11-digit product format
553190063
Labeler code
55319
Product ID
55319-063_4b931e99-fa6e-6400-e063-6394a90a9874
Type
HUMAN OTC DRUG
Nonproprietary name
FERRIC OXIDE RED
Dosage form
LOTION
Route
TOPICAL
Labeler
Family Dollar Stores, Inc
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1989-07-15
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
1a03331e-3676-451c-be22-9a547e8ae6e2Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-063-30Calamine177 mL in 1 BOTTLE, PLASTICLOTION17720

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-063CALAMINE (FERRIC OXIDE RED) LOTION [FAMILY DOLLAR SERVICES, INC.]18Current NDC, Legacy NDC, 1 package rows20240831_1a03331e-3676-451c-be22-9a547e8ae6e2.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 2 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Petroleum Skin ProtectantWHITE PETROLATUMYour Military Exchanges1a0aed14-8606-4676-b4b5-23dd415d43ac2026-09-02Warnings, Adverse reactionsExact identifier
application number: M016
Aloetouch Protect Fragrance FreeDIMETHICONEMedline Industries, LP81f0071b-2bf3-455b-9e5d-8f3ca20adcdf2026-09-01WarningsExact identifier
application number: M016
PURE PETROLATUMPETROLATUMVASA COSMETICS PRIVATE LIMITED5a57b197-3e18-b3ab-e063-6394a90aed822026-08-31WarningsExact identifier
application number: M016
HYDROPHORHYDROPHORAkron Pharma Inc.e6099df7-d418-479a-9d2e-ced523585aed2026-08-28WarningsExact identifier
application number: M016
Witch HazelWITCH HAZELUnited Natural Foods, Inc. dba UNFId2d1bd9e-7025-4151-95f2-a2f521dc2be82026-08-28Warnings, Adverse reactionsExact identifier
application number: M016
Daily MoisturizingDIMETHICONEYour Military Exchangese7af5488-1c49-41e9-9d8b-d519c61076992026-08-28Warnings, Adverse reactionsExact identifier
application number: M016
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
application number: M016
Estriol CreamESTRIOLGuangxi Keyun E-commerce Co., Ltd.4deadcb6-0d46-bdd7-e063-6294a90a26d72026-08-27WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP0d964138-f68d-dbf5-e063-6294a90a83202026-08-27WarningsExact identifier
application number: M016
Gembooxt ECZEMA RELIEF CreamHYDROCORTISONEGuangdong Quadrant Ecological Technology Co., Ltd.46490d65-f789-eaa2-e063-6294a90a623b2026-08-27WarningsExact identifier
application number: M016
Serawise Eczema ReliefOATMEALDrAnaMaria. Com LLCf0681436-d140-4e02-afe4-5b16de07afcd2026-08-26WarningsExact identifier
application number: M016
Hair Regrowth FoamGLYCERINShantou Ouhoe Technology Co., Ltd.59ef5953-e96f-5707-e063-6294a90a30942026-08-26WarningsExact identifier
application number: M016
Growth TreatmentGLYCERINShantou Ouhoe Technology Co., Ltd.59fe12eb-574f-a199-e063-6394a90abd062026-08-26WarningsExact identifier
application number: M016
Acne ReliefSALICYLIC ACID,NIACINAMIDE,PANTHENOL.Guangzhou Senmai Biotechnology Co.,Ltd.59db0143-de57-59d2-e063-6294a90a32a82026-08-25WarningsExact identifier
application number: M016
Witch HazelWITCH HAZELYour Military Exchanges4079fd56-55f3-4e69-93e0-7590c07fb7942026-08-25Warnings, Adverse reactionsExact identifier
application number: M016
Salicylic Acid Acne Gel CleanserSALICYLIC ACID,PANTHENOLGuangzhou Senmai Biotechnology Co.,Ltd.59eb395b-493b-efc9-e063-6294a90aa8912026-08-25WarningsExact identifier
application number: M016
ClaravieDIMETHICONEGentell LLC59c6da39-b5f1-8253-e063-6394a90a0e8f2026-08-24WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP0d94fd18-a120-e171-e063-6394a90ae9c02026-08-24WarningsExact identifier
application number: M016
MUSTELA Diaper Rash 1 2 3ZINC OXIDEExpanscience Laboratories d/b/a Mustela59cf1d1e-e951-9d58-e063-6394a90af0f32026-08-24WarningsExact identifier
application number: M016
ClaravieZINC OXIDE, DIMETHICONEGentell LLC598a5c0b-1e2f-1335-e063-6394a90ac4f42026-08-21WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617954calamine 8 % / zinc oxide 8 % Topical LotionPSN1a03331e-3676-451c-be22-9a547e8ae6e220
617954calamine 80 MG/ML / zinc oxide 80 MG/ML Topical LotionSCD1a03331e-3676-451c-be22-9a547e8ae6e220
617954calamine 8 % / zinc oxide 8 % Topical LotionSY1a03331e-3676-451c-be22-9a547e8ae6e220
617954Calamine 80 MG/ML / ZNO 80 MG/ML Topical LotionSY1a03331e-3676-451c-be22-9a547e8ae6e220

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55319-063-3055319006330177 mL in 1 BOTTLE, PLASTIC (55319-063-30) 177 ml1989-07-150000-00-00NoNoCurrent