Calamine Plus Pramoxine HCl

Product NDC
42507-956
11-digit product format
425070956
Labeler code
42507
Product ID
42507-956_43d523b4-726c-4dc9-e063-6394a90a40c5
Type
HUMAN OTC DRUG
Nonproprietary name
Calamine Plus Spray
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
HY-VEE, INC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-10-17
Substance
FERRIC OXIDE RED; ZINC OXIDE; PRAMOXINE HYDROCHLORIDE
Active strength
5; 75; 10 mg/g; mg/g; mg/g
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
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 Plus Pramoxine HCl
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FERRIC OXIDE RED5 mg/g
ZINC OXIDE75 mg/g
PRAMOXINE HYDROCHLORIDE10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1K09F3G675Internal UNII lookup
SOI2LOH54ZInternal UNII lookup
88AYB867L5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1544717Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
415ecfe9-3145-f23e-e063-6394a90adfd8Available 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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42507-956-01Calamine Plus Pramoxine HCl116 g in 1 CANAEROSOL, SPRAY1163

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 53 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZIMS MAX FREEZELIDOCAINE HYDROCHLORIDE AND MENTHOL,KOBAYASHI Healthcare International, Inc.e364ff83-4aaf-4897-a7da-06581bc321f22025-12-18WarningsExact identifier
application number: M017
Tiger Balm White Regular StrengthCAMPHOR (SYNTHETIC) AND MENTHOLHaw Par Healthcare Ltd.f406161e-a9c4-47d1-8b21-93b1b79380632025-12-17WarningsExact identifier
application number: M017
ResinolPETROLATUM AND RESORCINOLResiCal, Inc.03f57a4a-f94b-4ba6-b709-41cfb6e162612025-12-17WarningsExact identifier
application number: M017
HealthWise Maximum Pain ReliefLIDOCAINEVeridian Healthcareafc3c16d-0076-44b2-ae7e-5f36d4d8088e2025-12-17WarningsExact identifier
application number: M017
HealthWise Max Lidocaine plus MentholLIDOCAINE, MENTHOLVeridian Healthcaref39a27da-6799-4fc6-97ca-101eac4a93602025-12-17WarningsExact identifier
application number: M017
HealthWise Original MentholMENTHOLVeridian Healthcaree4bfb6b0-545e-4fbc-8538-4f41a6be10252025-12-17WarningsExact identifier
application number: M017
Welly Polka First Aid KitHYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEDongguan Shenglian Tins Products Co., Ltd.d7c4314c-c4c6-4adf-b384-3ac7a71083192025-12-17WarningsExact identifier
application number: M017
Frankincense and Myrrh Arthritis Pain TherapyMENTHOLWise Consumer Products2410a199-f4a3-da6c-e063-6394a90aaace2025-12-17WarningsExact identifier
application number: M017
LidocaineLIDOCAINE, MENTHOLVive Health LLC462d3b24-643e-91da-e063-6394a90a0e1d2025-12-17WarningsExact identifier
application number: M017
TheragesicMETHYL SALICYLATEMission Pharmacal Companydb6c0c77-0a20-d574-a98f-e6c9998b941f2025-12-17WarningsExact identifier
application number: M017
Teevodar Pain RelievingMENTHOLSod-e Biotech Ltd205b0fef-4f00-db2e-e063-6294a90a93b82025-12-17WarningsExact identifier
application number: M017
Frankincense and Myrrh Arthritis Pain ReliefMENTHOLWISE CONSUMER PRODUCTS CO.116045df-891b-f370-e063-6294a90abe422025-12-17WarningsExact identifier
application number: M017
Frankincense and Myrrh Intensive Foot TherapyMENTHOLWise Consumer Products23e56c6b-0f2b-721f-e063-6394a90a1ed02025-12-17WarningsExact identifier
application number: M017
Tiger Balm Ultra StrengthCAMPHOR (SYNTHETIC) AND MENTHOLHaw Par Healthcare Ltd.f0561804-e0f7-495d-9768-9b86a208c51e2025-12-17WarningsExact identifier
application number: M017
Kwan LoongMETHYL SALICYLATE AND MENTHOLHaw Par Healthcare Ltd.54bcb26e-786a-403e-9330-11ae9e3c013a2025-12-17WarningsExact identifier
application number: M017
Magsoothium Body Cooling FormulaMENTHOLUbu/Elements, Inc.f7fb6ac9-a920-a440-e053-6394a90aaa352025-12-16WarningsExact identifier
application number: M017
Magsoothium CBD Body LavenderMENTHOLUbu/Elements, Inc.f9b87fbe-b889-67a1-e053-6394a90acbcd2025-12-16WarningsExact identifier
application number: M017
Aquaphor Itch ReliefHYDROCORTISONEBeiersdorf Incb1d0333f-ba60-35d8-e053-2995a90af9322025-12-16WarningsExact identifier
application number: M017
Magsoothium CBD BodyMENTHOLUbu/Elements, Inc.00b2ef34-42d7-523c-e063-6294a90a753d2025-12-16WarningsExact identifier
application number: M017
GENTLECARE HAND AND SKIN SANITIZERBENZALKONIUM CHLORIDEPARAGON SOLUTIONS US, INC.16650277-fa62-485e-9a82-7763d2b501682025-12-16WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1544717calamine 8 % / pramoxine HCl 1 % Topical SprayPSN415ecfe9-3145-f23e-e063-6394a90adfd83
1544717calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical SpraySCD415ecfe9-3145-f23e-e063-6394a90adfd83
1544717calamine 8 % / pramoxine hydrochloride 1 % Topical SpraySY415ecfe9-3145-f23e-e063-6394a90adfd83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42507-956-0142507095601116 g in 1 CAN (42507-956-01) 116 g2025-10-17NoNoCurrent