Calmol 4

Product NDC
67492-104
11-digit product format
674920104
Labeler code
67492
Product ID
67492-104_41eb9348-e861-4ac7-e063-6294a90a96cf
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide and Cocoa Butter
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Resical Inc.
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2006-05-13
Substance
COCOA BUTTER; ZINC OXIDE
Active strength
2052; 270 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Calmol 4
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE2052 mg/1
COCOA BUTTER270 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
512OYT1CRRInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049137Internal RxNorm lookup
1113714Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5516f800-d3fa-4b90-a3eb-c0bdf3183b9bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67492-104-11Calmol 46 in 1 BLISTER PACKSUPPOSITORY612
67492-104-11Calmol 44 in 1 CARTONSUPPOSITORY412
67492-104-12Calmol 42 in 1 CARTONSUPPOSITORY212
67492-104-12Calmol 46 in 1 BLISTER PACKSUPPOSITORY612
67492-104-13Calmol 42 in 1 BLISTER PACKSUPPOSITORY212
67492-104-13Calmol 41 in 1 CARTONSUPPOSITORY112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67492-104-11EA - Each67492-104276af734-d50d-48c9-a09c-796616e1251012021-07-15
67492-104-12EA - Each67492-1044809ba74-b618-4043-9e90-e1431c926a2712021-07-15

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67492-104CALMOL 4 (ZINC OXIDE AND COCOA BUTTER) SUPPOSITORY [RESICAL INC.]11Current NDC, Legacy NDC, 6 package rows20241215_5516f800-d3fa-4b90-a3eb-c0bdf3183b9b.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 1 of 22 · 434 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gembooxt Topical Numbing CreamLIDOCAINEGuangdong Quadrant Ecological Technology Co., Ltd.49951a3e-3b62-3d66-e063-6294a90a93602026-08-12WarningsExact identifier
application number: M015
NumbMD Lidocaine Cream Anorectal(hemorrhoidal)LIDOCAINE 5%EveryMarket Inc52379055-d017-4d98-e063-6294a90a196c2026-08-12WarningsExact identifier
application number: M015
Nupharmisto NumbMD Lidocaine CreamLIDOCAINE 5%EveryMarket Inc52369a41-820d-cd7a-e063-6394a90ac6d12026-08-12WarningsExact identifier
application number: M015
Nupharmisto NumbMD Lidocaine CreamLIDOCAINE 5%EveryMarket Inc51d370b4-1c34-d203-e063-6394a90a80b12026-08-12WarningsExact identifier
application number: M015
Nupharmisto NumbMD 5% Lidocaine creamLIDOCAINE 5%EveryMarket Inc507d0c2c-9517-40f8-e063-6394a90a19962026-08-12WarningsExact identifier
application number: M015
Nupharmisto NumbMD LIDOCAINE cream anorectal (hemorrhoidal)LIDOCAINE CREAM ANORECTALEveryMarket Inc483d81a3-7493-3391-e063-6394a90a2e3d2026-08-12WarningsExact identifier
application number: M015
Numbing CreamLIDOCAINE100 KARMA INC35b5ba9d-da1d-55d6-e063-6294a90a5fa82026-08-12WarningsExact identifier
application number: M015
Treatonic hemorrhoid treatment5% LIDOCAINE100 KARMA INC41442fa7-c511-07ca-e063-6294a90a39922026-08-12WarningsExact identifier
application number: M015
Lidocaine numbing cream5% LIDOCAINE100 KARMA INC47380721-6633-4a50-e063-6394a90aca942026-08-12WarningsExact identifier
application number: M015
Treatonic 5% Lidocaine Cream5% LIDOCAINE CREAM100 KARMA INC47dc7630-9a74-1989-e063-6294a90a50bb2026-08-12WarningsExact identifier
application number: M015
Treatonic 5% Lidocaine Cream5% LIDOCAINE CREAM100 KARMA INC49e6b69f-bd6e-b415-e063-6394a90a8e652026-08-12WarningsExact identifier
application number: M015
THE SOLU TIONLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE HYDROCHLORIDESCALP TECH INC58793581-8826-9a74-e063-6294a90a24652026-08-06WarningsExact identifier
application number: M015
Lidocaine Numbing CreamLIDOCAINEGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.5457b3d7-e6b6-34a7-e063-6394a90aa2402026-08-03WarningsExact identifier
application number: M015
HEMORRHOIDALCREAMPROCUREPHENYLEPHRINE HCL, PETROLATUM, MINERAL OILTWIN MED, LLCe9c44756-1c98-41be-e053-2995a90a35b42026-08-03WarningsExact identifier
application number: M015
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEYYBA CORP582a0001-da1e-909a-e063-6394a90a2b112026-08-03WarningsExact identifier
application number: M015
up and upPHENYLEPHRINE HYDROCHLORIDETarget Corporationb42775ae-44fe-487e-b9ca-21d9687020a92026-07-29WarningsExact identifier
application number: M015
Acolye Numbing Cream Anorectal(Hemorrhoidal) CreamLIDOCAINEGuangdong Aimu Biological Technology Co., Ltd578fa642-ff30-e511-e063-6294a90a59872026-07-26WarningsExact identifier
application number: M015
CVS Topical Anesthetic HemorrhoidalDIBUCAINECVS PHARMACY, INC9f3d4fdb-ad82-4ab8-8a9e-252d027068ab2026-07-25WarningsExact identifier
application number: M015
Moisture BarrierMENTHOL 0.44%, ZINC OXIDE 20.6%Walgreen Company258f3392-0f42-21e8-e063-6294a90ae9ad2026-07-22WarningsExact identifier
application number: M015
RectaEase Hemorrhoid Relief CreamLIDOCAINETrifecta Pharmaceuticals USA LLCc054921a-9f1b-7c75-e053-2995a90a17382026-07-20WarningsExact identifier
application number: M015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1113714Calmol 4, 76 % / 10 % Rectal SuppositoryPSN5516f800-d3fa-4b90-a3eb-c0bdf3183b9b12
1049137cocoa butter 76 % / zinc oxide 10 % Rectal SuppositoryPSN5516f800-d3fa-4b90-a3eb-c0bdf3183b9b12
1113714cocoa butter 0.76 MG/MG / zinc oxide 0.1 MG/MG Rectal Suppository [Calmol]SBD5516f800-d3fa-4b90-a3eb-c0bdf3183b9b12
1049137cocoa butter 0.76 MG/MG / zinc oxide 0.1 MG/MG Rectal SuppositorySCD5516f800-d3fa-4b90-a3eb-c0bdf3183b9b12
1113714Calmol-4 (cocoa butter 76 % / zinc oxide 10 % ) Rectal SuppositorySY5516f800-d3fa-4b90-a3eb-c0bdf3183b9b12
1049137cocoa butter 0.76 MG/MG / ZNO 0.1 MG/MG Rectal SuppositorySY5516f800-d3fa-4b90-a3eb-c0bdf3183b9b12
1113714cocoa butter 0.76 MG/MG / ZNO 0.1 MG/MG Rectal Suppository [Calmol]SY5516f800-d3fa-4b90-a3eb-c0bdf3183b9b12
1049137cocoa butter 76 % / zinc oxide 10 % Rectal SuppositorySY5516f800-d3fa-4b90-a3eb-c0bdf3183b9b12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67492-104-11674920104114 BLISTER PACK in 1 CARTON (67492-104-11) / 6 SUPPOSITORY in 1 BLISTER PACK4 blister pack2006-05-130000-00-00NoNoCurrent
67492-104-12674920104122 BLISTER PACK in 1 CARTON (67492-104-12) / 6 SUPPOSITORY in 1 BLISTER PACK2 blister pack2006-05-130000-00-00NoNoCurrent
67492-104-13674920104131 BLISTER PACK in 1 CARTON (67492-104-13) / 2 SUPPOSITORY in 1 BLISTER PACK1 blister pack2006-05-130000-00-00NoNoCurrent