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 4 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HEMORRHOIDAL	MINERAL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE	CVS PHARMACY, INC	93482a9b-145b-42d4-96db-599c281a39f1	2026-06-10	Warnings	Exact identifier application number: M015
Oudetas Lidocaine Cream	LIDOCAINE CREAM	Guangzhou Jingliang Cosmetics Co., Ltd.	53f11395-f460-943f-e063-6294a90affef	2026-06-10	Warnings	Exact identifier application number: M015
Terramed Just Think Comfort Hemorrhoidal Wipes	LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE	Rida LLC	f6ad00e7-c7b8-40b8-80c2-6e6bf85098b3	2026-06-08	Warnings	Exact identifier application number: M015
Witch Hazel	WITCH HAZEL	CVS Pharmacy, Inc.	50f920da-b41a-480d-b3a0-df940caaee2d	2026-06-08	Warnings, Adverse reactions	Exact identifier application number: M015
Adellina Lidocaine Numbing Cream Topical Anorectal Cream	LIDOCAINE	Guangdong Aimu Biological Technology Co., Ltd	5356cf53-935d-a02f-e063-6394a90a6e5a	2026-06-05	Warnings	Exact identifier application number: M015
Hemorrhoidal	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM	HyVee Inc	b867f691-7a13-4659-b664-06aa36899310	2026-06-03	Warnings	Exact identifier application number: M015
Healcome Lidocaine Numbing Cream	LIDOCAINE	YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD	9b4eac02-1b1f-4630-92b4-b1d8c21abab5	2026-05-29	Warnings	Exact identifier application number: M015
Terramed Just Think Comfort Armor Antifungal Body Wash Lavender and chamomile	TOLNAFTATE	Rida LLC	5517c43f-03b2-499a-a217-d9cba3fb9fd2	2026-05-27	Warnings	Exact identifier application number: M015
Terramed Just Think Comfort Armor Antifungal Body Wash Citrus	TOLNAFTATE	Rida LLC	b4c5da66-5928-4352-ab90-fd46039e7955	2026-05-27	Warnings	Exact identifier application number: M015
Terramed Just Think Comfort GynoCare BV Guard Intimate Wipes	PRAMOXINE HYDROCHLORIDE	Rida LLC	bb29f156-37b8-400e-802b-3e2671cb7dc8	2026-05-27	Warnings	Exact identifier application number: M015
myDerm MEDICAL NEW Soothing Hemorrhoidal	WITCH HAZEL PENYLEPHRINE LIDOCAINE	Inspec Solutions	2ff42501-7730-42de-99dd-6fc53bbdf25f	2026-05-27	Warnings	Exact identifier application number: M015
Terramed Just Think Comfort Armor Antifungal Body Wash Icy Cool Menthol	TOLNAFTATE	Rida LLC	8b15cb3b-f7cb-4a80-94b2-eeeafc9794e8	2026-05-27	Warnings	Exact identifier application number: M015
Lidocaine Roll-on	LIDOCAINE	YYBA Corp	52d060df-2095-dd68-e063-6394a90a7740	2026-05-27	Warnings	Exact identifier application number: M015
PUVIDA NUMBING Cream Anorectal (Hemorrhoidal) Cream	LIDOCAINE 5% NUMBING CREAM ANORECTAL (HEMORRHOIDAL) CREAM	Jiangxi Yudexi Pharmaceutical Co., LTD	52a25b97-7721-6410-e063-6394a90a228f	2026-05-25	Warnings	Exact identifier application number: M015
Arlun LIDOCAINE Cream	LIDOCAINE CREAM	Guangzhou Jingliang Cosmetics Co., Ltd.	5241c26b-6c91-65a5-e063-6394a90a2477	2026-05-20	Warnings	Exact identifier application number: M015
tuiwaro LIDOCAINE Cream	LIDOCAINE CREAM	Guangzhou Jingliang Cosmetics Co., Ltd.	5223b7fe-6aba-c77b-e063-6394a90ad27b	2026-05-18	Warnings	Exact identifier application number: M015
HEMORRHOIDAL WITH LIDOCAINE	GLYCERIN, LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE, WHITE PETROLATUM	CVS PHARMACY, INC	4d870c68-9e72-464e-b0b8-900d0d661e43	2026-05-14	Warnings	Exact identifier application number: M015
Oxify	LIDOCAINE 5%	Weeks & Leo Compnay, INC.	51cd58f7-c1c9-f4e2-e063-6294a90ad970	2026-05-14	Warnings	Exact identifier application number: M015
Lidocaine anorectal cream	LIDOCAINE 5%	EveryMarket Inc	1604daec-812f-4684-ba98-fbcda07a7461	2026-05-12	Warnings	Exact identifier application number: M015
PREPARATION H SOOTHING RELIEF CLEANSING AND COOLING WIPES	WITCH HAZEL	Haleon US Holdings LLC	485437a8-b2e9-4acf-a20e-edb1f08a9cae	2026-05-11	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