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
Ingredient	Strength
ZINC OXIDE	270 mg/1
COCOA BUTTER	2052 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SOI2LOH54Z	Internal UNII lookup
512OYT1CRR	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
5516f800-d3fa-4b90-a3eb-c0bdf3183b9b	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67492-104-11	Calmol 4	6 in 1 BLISTER PACK	SUPPOSITORY	6	12
67492-104-11	Calmol 4	4 in 1 CARTON	SUPPOSITORY	4	12
67492-104-12	Calmol 4	2 in 1 CARTON	SUPPOSITORY	2	12
67492-104-12	Calmol 4	6 in 1 BLISTER PACK	SUPPOSITORY	6	12
67492-104-13	Calmol 4	2 in 1 BLISTER PACK	SUPPOSITORY	2	12
67492-104-13	Calmol 4	1 in 1 CARTON	SUPPOSITORY	1	12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67492-104-11	EA - Each	67492-104	276af734-d50d-48c9-a09c-796616e12510	1	2021-07-15
67492-104-12	EA - Each	67492-104	4809ba74-b618-4043-9e90-e1431c926a27	1	2021-07-15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
COCOA BUTTER	ACTIVE INGREDIENT	512OYT1CRR	CALMOL 4 (ZINC OXIDE AND COCOA BUTTER) SUPPOSITORY [RESICAL INC.]	1
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	CALMOL 4 (ZINC OXIDE AND COCOA BUTTER) SUPPOSITORY [RESICAL INC.]	1
COCOA BUTTER	ACTIVE MOIETY	512OYT1CRR	CALMOL 4 (ZINC OXIDE AND COCOA BUTTER) SUPPOSITORY [RESICAL INC.]	1
ZINC CATION	ACTIVE MOIETY	13S1S8SF37	CALMOL 4 (ZINC OXIDE AND COCOA BUTTER) SUPPOSITORY [RESICAL INC.]	1
BISMUTH SUBGALLATE	INACTIVE INGREDIENT	YIW503MI7V	CALMOL 4 (ZINC OXIDE AND COCOA BUTTER) SUPPOSITORY [RESICAL INC.]	1
FAT, HARD	INACTIVE INGREDIENT	8334LX7S21	CALMOL 4 (ZINC OXIDE AND COCOA BUTTER) SUPPOSITORY [RESICAL INC.]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	CALMOL 4 (ZINC OXIDE AND COCOA BUTTER) SUPPOSITORY [RESICAL INC.]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	CALMOL 4 (ZINC OXIDE AND COCOA BUTTER) SUPPOSITORY [RESICAL INC.]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	CALMOL 4 (ZINC OXIDE AND COCOA BUTTER) SUPPOSITORY [RESICAL INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67492-104	CALMOL 4 (ZINC OXIDE AND COCOA BUTTER) SUPPOSITORY [RESICAL INC.]	11	Current NDC, Legacy NDC, 6 package rows	20241215_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 13 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GoodSense Hemorrhoidal Pain Relief	GLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCL	Perrigo Direct, Inc	2e5f699d-45e8-6451-e063-6394a90a8ad8	2025-07-20	Warnings	Exact identifier application number: M015
Good Sense Hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	L. Perrigo Company	379f8738-a871-4b09-abd1-c86386dfee04	2025-07-15	Warnings	Exact identifier application number: M015
Maximum Strength Hemorrhoidal Pads	WITCH HAZEL	Walmart, Inc.	6dd8d3d9-5109-4869-917b-9521e9ba1ed0	2025-07-14	Warnings	Exact identifier application number: M015
Nikzon Hemorrhoidal	GLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDE	Genomma Lab USA	8f9a9939-2c99-489f-b597-9a51ec2684f9	2025-07-14	Warnings	Exact identifier application number: M015
ReVIVOL-XR	PHENYLEPHRINE HYDROCHLORIDE	Unipack LLC	2950fe83-a2a4-4ed4-b645-69d6fd2381ae	2025-07-13	Warnings	Exact identifier application number: M015
medicated wipes	WITCH HAZEL	Meijer Distribution Inc.	ba0f3f9a-95d1-4d8a-86d1-2c25c945118c	2025-07-11	Warnings	Exact identifier application number: M015
hemorrhoidal pads	WITCH HAZEL	Meijer Distribution Inc.	53e39d22-a89e-4f95-8c64-abeb50f72ce7	2025-07-11	Warnings	Exact identifier application number: M015
INVIGOR OH	LIDOCAINE	Natureplex LLC	7c7b536d-e41a-4017-9df9-982e2e9cfe4e	2025-07-10	Warnings	Exact identifier application number: M015
Maximum Strength Hemorrhoidal Cream with Aloe	GLYCERIN, PHENYLEPHINE HCI, PRAMOXINE HCI, PETROLATUM	Chain Drug Marketing Association	396ea654-8be1-591a-e063-6294a90a11e2	2025-07-08	Warnings	Exact identifier application number: M015
PREPARATION H SOOTHING RELIEF ANTI-ITCH	HYDROCORTISONE	Haleon US Holdings LLC	d6148d77-ef6f-4552-b5ba-43b429923f19	2025-07-07	Warnings	Exact identifier application number: M015
Rectal Care Cream	RECTAL CARE CREAM	Allegiant Health	ce585082-ad39-4b6f-a756-0d9a81a13eb8	2025-07-07	Warnings	Exact identifier application number: M015
Bisacodyl Laxative	BISACODYL LAXATIVE SUPPOSITORIES	Neilmed Pharmaceuticals Inc.	35cb0386-a662-6893-e063-6294a90aa71a	2025-07-03	Warnings	Exact identifier application number: M015
Hemorrhoidal Cream	GLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUM	Trifecta Pharmaceuticals Usa Llc	38cf4e43-280b-eb96-e063-6294a90a5949	2025-07-02	Warnings	Exact identifier application number: M015
TN Dickinsons Medicated Cooling Foam Hemorrhoidal Relief	WITCH HAZEL	Dickinson Brands Inc.	deca8ae2-53a3-4c90-aa10-45354e2cdab8	2025-06-27	Warnings	Exact identifier application number: M015
Glycerin Laxative	GLYCERIN LAXATIVE SUPPOSITORIES	Neilmed Pharmaceuticals Inc.	35cc266a-196f-16ce-e063-6394a90a24af	2025-06-20	Warnings	Exact identifier application number: M015
Phenylephrine Hemorrhoidal	HEMORRHOIDAL SUPPOSITORIES	Neilmed Pharmaceuticals Inc.	35ccb320-e902-3d1a-e063-6294a90a68d5	2025-06-20	Warnings	Exact identifier application number: M015
ProCure Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Twin Med LLC	37a4cc43-0d53-f1bf-e063-6394a90a2dc9	2025-06-15	Warnings	Exact identifier application number: M015
Hemorrhoidal Pain Relief	HEMORRHOIDAL PAIN RELIEF OINTMENT	Neilmed Pharmaceuticals Inc.	374d89b6-9305-9adf-e063-6394a90adb32	2025-06-11	Warnings	Exact identifier application number: M015
Dermoplast Post Partum	BENZOCAINE	Advantice Health, LLC	374dced3-6527-b458-e063-6394a90a911e	2025-06-11	Warnings	Exact identifier application number: M015
foster and thrive hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Strategic Sourcing Services LLC	fb3bc359-b06b-4995-aa68-0117a639dff2	2025-06-11	Warnings	Exact identifier application number: M015

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE
512OYT1CRR	COCOA BUTTER	8002-31-1	COCOA BUTTER

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1113714	Calmol 4, 76 % / 10 % Rectal Suppository	PSN	5516f800-d3fa-4b90-a3eb-c0bdf3183b9b	12
1049137	cocoa butter 76 % / zinc oxide 10 % Rectal Suppository	PSN	5516f800-d3fa-4b90-a3eb-c0bdf3183b9b	12
1113714	cocoa butter 0.76 MG/MG / zinc oxide 0.1 MG/MG Rectal Suppository [Calmol]	SBD	5516f800-d3fa-4b90-a3eb-c0bdf3183b9b	12
1049137	cocoa butter 0.76 MG/MG / zinc oxide 0.1 MG/MG Rectal Suppository	SCD	5516f800-d3fa-4b90-a3eb-c0bdf3183b9b	12
1113714	Calmol-4 (cocoa butter 76 % / zinc oxide 10 % ) Rectal Suppository	SY	5516f800-d3fa-4b90-a3eb-c0bdf3183b9b	12
1049137	cocoa butter 0.76 MG/MG / ZNO 0.1 MG/MG Rectal Suppository	SY	5516f800-d3fa-4b90-a3eb-c0bdf3183b9b	12
1113714	cocoa butter 0.76 MG/MG / ZNO 0.1 MG/MG Rectal Suppository [Calmol]	SY	5516f800-d3fa-4b90-a3eb-c0bdf3183b9b	12
1049137	cocoa butter 76 % / zinc oxide 10 % Rectal Suppository	SY	5516f800-d3fa-4b90-a3eb-c0bdf3183b9b	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67492-104-11	67492010411	4 BLISTER PACK in 1 CARTON (67492-104-11) / 6 SUPPOSITORY in 1 BLISTER PACK	4 blister pack	2006-05-13	0000-00-00	No	No	Current
67492-104-12	67492010412	2 BLISTER PACK in 1 CARTON (67492-104-12) / 6 SUPPOSITORY in 1 BLISTER PACK	2 blister pack	2006-05-13	0000-00-00	No	No	Current
67492-104-13	67492010413	1 BLISTER PACK in 1 CARTON (67492-104-13) / 2 SUPPOSITORY in 1 BLISTER PACK	1 blister pack	2006-05-13	0000-00-00	No	No	Current