FDA.reportPublic FDA data

Calaclear

Product NDC
49035-402
11-digit product format
490350402
Labeler code
49035
Product ID
49035-402_52b86437-892d-9ba2-e063-6294a90a7adb
Type
HUMAN OTC DRUG
Nonproprietary name
Pramoxine Hydrochloride and Zinc Acetate
Dosage form
LOTION
Route
TOPICAL
Labeler
Wal-Mart Stores, Inc.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-01-03
Substance
PRAMOXINE HYDROCHLORIDE; ZINC ACETATE
Active strength
10; 1 mg/mL; 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
Calaclear
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAMOXINE HYDROCHLORIDE10 mg/mL
ZINC ACETATE1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
88AYB867L5Internal UNII lookup
FM5526K07AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1234546Internal RxNorm lookup
1248193Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
61e76e2a-fc46-7a64-e053-2991aa0a56a8Available 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
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
49035-402-96Calaclear177 mL in 1 BOTTLE, PLASTICLOTION1778

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-402CALACLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [WAL-MART STORES, INC.]7Current NDC, Legacy NDC, 1 package rows20231220_61e76e2a-fc46-7a64-e053-2991aa0a56a8.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
1248193CALACLEAR 1 % / 0.1 % Topical LotionPSN61e76e2a-fc46-7a64-e053-2991aa0a56a88
1234546pramoxine HCl 1 % / zinc acetate 0.1 % Topical LotionPSN61e76e2a-fc46-7a64-e053-2991aa0a56a88
1248193pramoxine hydrochloride 10 MG/ML / zinc acetate 1 MG/ML Topical Lotion [Calaclear]SBD61e76e2a-fc46-7a64-e053-2991aa0a56a88
1234546pramoxine hydrochloride 10 MG/ML / zinc acetate 1 MG/ML Topical LotionSCD61e76e2a-fc46-7a64-e053-2991aa0a56a88
1248193Calaclear (pramoxine hydrochloride 1 % / zinc acetate 0.1 % ) Topical LotionSY61e76e2a-fc46-7a64-e053-2991aa0a56a88
1234546pramoxine HCl 1 % / zinc acetate 0.1 % Topical LotionSY61e76e2a-fc46-7a64-e053-2991aa0a56a88

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-402-9649035040296177 mL in 1 BOTTLE, PLASTIC (49035-402-96) 177 ml2018-01-030000-00-00NoNoCurrent