FDA.reportPublic FDA data

Calamine

Product NDC
11344-136
11-digit product format
113440136
Labeler code
11344
Product ID
11344-136_5c148e64-6bd1-2028-e063-6294a90a2872
Type
HUMAN OTC DRUG
Nonproprietary name
Calamine, Pramoxind HCl
Dosage form
LOTION
Route
TOPICAL
Labeler
Nice-Pak Products, LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-09-08
Substance
FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE
Active strength
80; 10 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
PRAMOXINE HYDROCHLORIDE10 mg/mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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
11344-136-30Calamine177 mL in 1 BOTTLE, PLASTICLOTION1773

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11344-136CALAMINE (CALAMINE, PRAMOXIND HCL) LOTION [CONSUMER PRODUCT PARTNERS, LLC]1Current NDC, 1 package rows20240731_9089e23e-ca4a-454f-8dcc-ff5a29a5a335.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 24 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VERADEX-EPETROLATUM AND LANOLINABBE Laboratories, Inc.00100102-c245-4b63-a4ff-794cacda6f172026-01-24WarningsExact identifier
application number: M016
HydrocortisoneDRS. HYDROCORTISONEOL PHARMA TECH,LLCb0eac8f3-bb80-6563-e053-2995a90a83c92026-01-22WarningsExact identifier
application number: M016
Eczema Reliegf Skin Protectant EQBCOLLOIDAL OATMEAL 2%Walmart37132a0d-37c5-4b21-9673-5f853b3a62482026-01-20WarningsExact identifier
application number: M016
Skin Relief CreamHYDROCORTISONESpa de Soleil0a90b77a-4be4-71c5-e063-6294a90a8e412026-01-20WarningsExact identifier
application number: M016
Cold Sore BandageCOLD SORE BANDAGEShenzhen Hengdasheng Technology Co., Ltd47f588a2-a69b-cffe-e063-6294a90a0ed42026-01-17WarningsExact identifier
application number: M016
Nail Repairs PatchesGLYCERINShantou Ximonth Biotechnology Co., Ltd.48793a50-89a7-dba9-e063-6394a90a70562026-01-16WarningsExact identifier
application number: M016
HAND SANITIZERHAND SANITIZERGuangdong bangze medicine co., ltd40018618-8f95-f6db-e063-6394a90ac7dd2026-01-16WarningsExact identifier
application number: M016
Lemon GlycerinGLYCERINJianerkang Medical Co., Ltdedee14da-13d8-4bc2-9c37-cfc353763d112026-01-16WarningsExact identifier
application number: M016
WORKMANS FRIEND SUPERIOR BARRIER SKINDIMETHICONESolvChem, Inc.da12ac2c-1af9-47b1-aa5f-77acb48535ba2026-01-16WarningsExact identifier
application number: M016
Walgreens Vitamin A and D skin protectantLANOLIN, PETROLATUMWalgreen Company9aa6c7f2-0923-4d51-8b9b-63f9a724937a2026-01-15WarningsExact identifier
application number: M016
INCONTINENCE CARE WIPEDIMETHICONECardinal Health 200, Inc.1ac34c94-9e3b-45f2-ba19-a07dcd3941dd2026-01-15WarningsExact identifier
application number: M016
Alcohol Hand SanitizerALCOHOL HAND SANITIZERGuangdong bangze medicine co., ltd2e8b5afe-6ff8-3e9b-e063-6394a90ad7032026-01-14WarningsExact identifier
application number: M016
Alcohol SanitizerALCOHOL SANITIZER SPRAYGuangdong bangze medicine co., ltd2e9db49b-35ce-00d5-e063-6294a90acf352026-01-14WarningsExact identifier
application number: M016
GG XEROZINE 15SKIN PROTECTANTGERI-GENTLE CORPORATIONe6881c6d-f584-26d0-e053-2995a90a38732026-01-14WarningsExact identifier
application number: M016
Medpura Zinc Oxide 20%MEDPURA ZINC OXIDE 20%Akron Pharma Inc.3a63aaea-087e-4115-8478-64d416e6085f2026-01-14WarningsExact identifier
application number: M016
Walgreens Baby PetroleumPETROLATUMWalgreen Companye79f2bc2-e53b-4d01-9f9b-d9bd5c3b230d2026-01-14WarningsExact identifier
application number: M016
Walgreens Cocoa Butter JellyPETROLEUMWalgreens32b84286-471a-4d15-80fb-2f516dc1d6ea2026-01-14WarningsExact identifier
application number: M016
Hydrating Healing Skin ProtectantPETROLATUM OINTMENTCVS Pharmacyc129c2b0-10d5-4b5d-ac5c-2e2512e612792026-01-14WarningsExact identifier
application number: M016
Multi-Purpose Skin ProtectantA AND D OINTMENTCVS Pharmacy60bd0095-25d3-44af-9502-0c63b3d25e662026-01-14WarningsExact identifier
application number: M016
Kenkoderm Eczema Honey Intensive Soothing BalmKENKODERM ECZEMA HONEY INTENSIVE SOOTHING BALMGuangzhou Ariel Biotech Co., Ltd.48652b9c-4063-cc16-e063-6394a90a3b862026-01-14WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234532calamine 8 % / pramoxine HCl 1 % Topical LotionPSN9089e23e-ca4a-454f-8dcc-ff5a29a5a3353
1234532calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical LotionSCD9089e23e-ca4a-454f-8dcc-ff5a29a5a3353
1234532calamine 8 % / pramoxine hydrochloride 1 % Topical LotionSY9089e23e-ca4a-454f-8dcc-ff5a29a5a3353

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11344-136-3011344013630177 mL in 1 BOTTLE, PLASTIC (11344-136-30) 177 ml2016-09-08NoNoCurrent