FDA.reportPublic FDA data

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
ZINC OXIDE; COCOA BUTTER
Active strength
270; 2052 mg/1; mg/1
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
Calmol 4
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE270 mg/1
COCOA BUTTER2052 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#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
COCOA BUTTERACTIVE INGREDIENT512OYT1CRRCALMOL 4 (ZINC OXIDE AND COCOA BUTTER) SUPPOSITORY [RESICAL INC.]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZCALMOL 4 (ZINC OXIDE AND COCOA BUTTER) SUPPOSITORY [RESICAL INC.]1
COCOA BUTTERACTIVE MOIETY512OYT1CRRCALMOL 4 (ZINC OXIDE AND COCOA BUTTER) SUPPOSITORY [RESICAL INC.]1
ZINC CATIONACTIVE MOIETY13S1S8SF37CALMOL 4 (ZINC OXIDE AND COCOA BUTTER) SUPPOSITORY [RESICAL INC.]1
BISMUTH SUBGALLATEINACTIVE INGREDIENTYIW503MI7VCALMOL 4 (ZINC OXIDE AND COCOA BUTTER) SUPPOSITORY [RESICAL INC.]1
FAT, HARDINACTIVE INGREDIENT8334LX7S21CALMOL 4 (ZINC OXIDE AND COCOA BUTTER) SUPPOSITORY [RESICAL INC.]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4CALMOL 4 (ZINC OXIDE AND COCOA BUTTER) SUPPOSITORY [RESICAL INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCALMOL 4 (ZINC OXIDE AND COCOA BUTTER) SUPPOSITORY [RESICAL INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCALMOL 4 (ZINC OXIDE AND COCOA BUTTER) SUPPOSITORY [RESICAL INC.]1

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 22 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Family wellnessMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLFRONT PHARMACEUTICAL PLCcfdd61e3-e12e-491c-b2a8-90fae19e88702023-10-27WarningsExact identifier
application number: M015
Family WellnessGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, PETROLATUMFRONT PHARMACEUTICAL PLCeb1785f4-5876-443b-b175-9b59d65d1a482023-10-26WarningsExact identifier
application number: M015
CVS Health Hemorrhoidal CreamGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMFRONT PHARMACEUTICAL PLCcb448d78-553c-4e65-80c5-d4b31d7b36612023-10-26WarningsExact identifier
application number: M015
Family WellnessPHENYLEPHRINE HCL, PETROLATUM, MINERALZhejiang Jingwei Pharmaceutical Co., Ltd.bfa195d7-d87f-43b5-bbf1-7ec3a451de052023-10-25WarningsExact identifier
application number: M015
MAXIMUM STRENGTH HEMORRHOIDAL RELIEF with Finger CotsLIDOCAINECVS PHARMACY, INC82aa128a-44cd-4907-b0f7-8a31e086d3e62023-10-25WarningsExact identifier
application number: M015
TheraPlus PlusPHENYLEPHRINE HCIZhejiang Jingwei Pharmaceutical Co., Ltd.edf9f8d5-f55d-4c31-adfb-ba77ca24cc3d2023-10-25WarningsExact identifier
application number: M015
Assured Bikini Smooth CreamLIDOCAINEZhejiang Jingwei Pharmaceutical Co., Ltd.fb9ddde3-3f40-467e-8aff-26570144f0fc2023-10-25WarningsExact identifier
application number: M015
Hemorrhoidal CreamGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUMCardinal Health 110, LLC. dba Leader85a51d5c-679e-1959-e053-2a91aa0a76d52023-10-25WarningsExact identifier
application number: M015
Family WellnessGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, PETROLATUMZhejiang Jingwei Pharmaceutical Co., Ltd.fde9cd90-d63c-4058-b46e-511fecea36ec2023-10-24WarningsExact identifier
application number: M015
Lidocaine 5%LIDOCAINEApnar Pharma LPceedce20-5723-5a9a-e053-2a95a90a17a12023-10-21WarningsExact identifier
application number: M015
Numquick Topical AnalgesicEPINEPHRINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDEUnit Dose, Ltd.3f64cbd3-6745-4397-9767-3adc3b301e0e2023-10-19WarningsExact identifier
application number: M015
Healquick Tattoo BalmPETROLATUMUnit Dose, Ltd.96f92c82-a79a-4d7e-ba0c-5ea67e2b6e862023-10-19WarningsExact identifier
application number: M015
Numpot Topical AnestheticLIDOCAINE, PETROLATUMUnit Dose, Ltd.9143b50b-7d76-4545-aa2e-1bb77ffb44ae2023-10-19WarningsExact identifier
application number: M015
Microcaine Topical AnalgesicLIDOCAINEUnit Dose, Ltd.5e8fa8b5-0524-4201-91e1-83e59a8f04152023-10-19WarningsExact identifier
application number: M015
NumstickPETROLATUM, LIDOCAINEUnit Dose, Ltd.127bbd87-5402-4da2-abf3-dac6367735ec2023-10-18WarningsExact identifier
application number: M015
ADVANCED NUMB Topical AnestheticLIDOCAINE HYDROCHLORIDEUber Scientific, LLC859d1cad-badf-4c42-9b08-daacb3fae8b42023-10-13WarningsExact identifier
application number: M015
Hemorrhoidal Pain Relief with Aloe and VitaminEHEMORRHOIDAL PAIN RELIEF WITH ALOE AND VITAMINENeilMed pharmaceuticals Inc.076b5021-8ba0-0204-e063-6294a90a33372023-10-11WarningsExact identifier
application number: M015
Zensa Numbing GelLIDOCAINE 5%, PHENYLEPHRINE HYDROCHLORIDE 0.25%Alera Skin Care Products Inc.065a6eec-3896-0da8-e063-6394a90a849d2023-09-27WarningsExact 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