Rite Aid Calamine

Product NDC
11822-4352
11-digit product format
118224352
Labeler code
11822
Product ID
11822-4352_0c9402f4-357f-6421-e063-6394a90a6839
Type
HUMAN OTC DRUG
Nonproprietary name
Calamine 8% and Zinc Oxide 8%
Dosage form
LOTION
Route
TOPICAL
Labeler
Rite Aid Corporation
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1998-03-25
Substance
ZINC OXIDE
Active strength
160 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
Rite Aid Calamine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE160 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
5df71189-9b36-9dee-e053-2a91aa0a9e49Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-4352-9Rite Aid Calamine177 mL in 1 BOTTLE, PLASTICLOTION1775

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-4352RITE AID CALAMINE (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [RITE AID CORPORATION]5Current NDC, Legacy NDC, 1 package rows20231216_5df71189-9b36-9dee-e053-2a91aa0a9e49.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 65 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HEB CalagesicZINC ACETATE AND PRAMOXINE HYDROCHLORIDEH E B5d579680-6bcb-1161-e053-2991aa0aead12023-12-18WarningsExact identifier
application number: M016
Publix Clear Anti-ItchZINC ACETATE AND PRAMOXINE HYDROCHLORIDEPublix5d6b905f-ed30-1ab7-e053-2a91aa0a816b2023-12-18WarningsExact identifier
application number: M016
Humco CalaclearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEHumco Holding Group, Inc.5fca3a73-6d66-496b-bd33-6e044f9039bc2023-12-15WarningsExact identifier
application number: M016
Calamine Phenolated Topical SuspensionCALAMINE AND ZINC OXIDE AND PHENOLHumco Holding Group, Inca3816729-be2b-4b4f-a609-953576cd2e3b2023-12-15WarningsExact identifier
application number: M016
Humco Mineral Oil LightMINERAL OILHumco Holding Group, Inc.753f35c3-1420-4817-ba63-b737a9c99a1d2023-12-15WarningsExact identifier
application number: M016
Humco Witch HazelWITCH HAZELHumco Holding Group, Inc.3cf07016-a129-49ca-8fad-b67dda5aa0092023-12-15WarningsExact identifier
application number: M016
Rite Aid CalamineCALAMINE 8% AND ZINC OXIDE 8%Rite Aid Corporation5df71189-9b36-9dee-e053-2a91aa0a9e492023-12-15WarningsExact identifier
application number: M016
ndc (product): 11822-4352
GNP Witch HazelWITCH HAZELAmerisource Bergen45ac839d-215d-4c5f-8ae5-5e111d1700612023-12-14WarningsExact identifier
application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 Skin ProtectantGLYCERINL'Oreal USA Products Inc32eaaaab-41bd-4efe-a71d-92e3a702c1e52023-12-11WarningsExact identifier
application number: M016
La Roche Posay Laboratoire Dermatologique Lipikar Eczema ReliefOATMEALCOSMETIQUE ACTIVE PRODUCTIONe555de17-9b42-4125-a17b-467bc1d179d72023-12-11WarningsExact identifier
application number: M016
La Roche Posay Laboratoire Dermatologique Lipikar Eczema Soothing ReliefOATMEALL'Oreal USA Products Incf7b71606-0044-4729-82e8-4514331806a02023-12-11WarningsExact identifier
application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5GLYCERINCosmetique Active Production01c8a0d5-bcd1-4639-be45-530a226401f02023-12-11WarningsExact identifier
application number: M016
Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen SPF 15CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONECarma Laboratories, Inc.0bc6812a-5c2a-7bb9-e063-6294a90a36e32023-12-05WarningsExact identifier
application number: M016
Carmex Classic Lip Balm Medicated Free Strawberry Stick Sunscreen SPF 15CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONECarma Laboratories, Inc.34fae56e-367d-4659-af2d-1c9ddaf1639c2023-12-05WarningsExact identifier
application number: M016
Diaper Rash Cream 2.5ozZINC OXIDERejoice International Corp.0ba98cdf-489e-dc2a-e063-6294a90adb382023-12-04WarningsExact identifier
application number: M016
Diaper Rash Cream 2.5ozZINC OXIDEChina Ningbo Shangge Cosmetics Technology Corp.0baa8a14-8655-d77c-e063-6294a90ab8aa2023-12-04WarningsExact identifier
application number: M016
THERAPLEX Eczema TherapyOATMEALTHERAPLEX, LLC86472a3d-7138-4141-8422-ab20c17a46e02023-12-04WarningsExact identifier
application number: M016
SOOTHE Moisturizing Rescue CreamOATMEALRodan & Fields91163267-c2aa-47b3-b290-d1605536d8062023-12-04WarningsExact identifier
application number: M016
Manzatin-E Diaper Rash Skin ProtectantZINC OXIDELaboratorios Zepol S.A.cafd084f-8493-4d6e-b256-2d4b4282f8662023-12-01WarningsExact identifier
application number: M016
Manzatin Diaper Rash Skin ProtectantZINC OXIDELaboratorios Zepol S.A.5c1618a4-ca08-4814-a556-74e79db618b92023-12-01WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617954calamine 8 % / zinc oxide 8 % Topical LotionPSN5df71189-9b36-9dee-e053-2a91aa0a9e495
617954calamine 80 MG/ML / zinc oxide 80 MG/ML Topical LotionSCD5df71189-9b36-9dee-e053-2a91aa0a9e495
617954calamine 8 % / zinc oxide 8 % Topical LotionSY5df71189-9b36-9dee-e053-2a91aa0a9e495
617954Calamine 80 MG/ML / ZNO 80 MG/ML Topical LotionSY5df71189-9b36-9dee-e053-2a91aa0a9e495

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-4352-911822435209177 mL in 1 BOTTLE, PLASTIC (11822-4352-9) 177 ml2017-11-130000-00-00NoNoCurrent