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 5 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DRMITSUI MEDICAL HAEMORRHOID	PHENYLEPHRINE HCI WITCH HAZEL	YIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED	51720221-893b-cade-e063-6394a90adaec	2026-05-10	Warnings	Exact identifier application number: M015
Glycerin	GLYCERIN SUPPOSITORIES	Neilmed Pharmaceuticals Inc.	374a2ca3-ee04-09a7-e063-6394a90ab760	2026-05-05	Warnings	Exact identifier application number: M015
Dr. Numb	LIDOCAINE	Shinpharma Inc	32ab24b4-dcec-4a09-e054-00144ff88e88	2026-04-30	Warnings	Exact identifier application number: M015
Dr. Numb	LIDOCAINE	Shinpharma Inc	c2c0cb17-401a-4ba2-aa04-64c9b43cd21b	2026-04-30	Warnings	Exact identifier application number: M015
Dr. Numb	LIDOCAINE	Shinpharma Inc	e840fba4-86ff-9da0-e053-2995a90a221a	2026-04-30	Warnings	Exact identifier application number: M015
FAMILY Wellness MEDICATED HEMORRHOIDAL WIPES	WITCH HAZEL	Family Dollar Stores, Inc	3f6f68c0-787a-48eb-b042-d4df90ea7e03	2026-04-17	Warnings	Exact identifier application number: M015
Equaline Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	a6ed1987-37ad-4bfd-8cea-f03426953f5a	2026-04-16	Warnings	Exact identifier application number: M015
Verdibliss HEMORRHOID RELIEF OINTMENTS	LIDOCAINE, PHENYLEPHRINE	Guangdong Quadrant Ecological Technology Co., Ltd.	4f1634d5-7667-b354-e063-6394a90a34e7	2026-04-10	Warnings	Exact identifier application number: M015
Hemorrhoidal Cream with Lidocaine	GLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUM	Trifecta Pharmaceuticals Usa Llc	4f1ef866-c4af-989b-e063-6294a90a148e	2026-04-10	Warnings	Exact identifier application number: M015
Thera Plus Hemorrhoidal	GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUM	Fourstar Group USA, Inc.	5d63bf97-29d2-4c71-97c3-85f425e86207	2026-04-07	Warnings	Exact identifier application number: M015
Walgreens Pain Relief with Lidocaine	LIDOCAINE, PHENYLEPHRINE HCL	Walgreens Co	3ce78f2f-0264-f406-e063-6294a90a7e03	2026-04-01	Warnings	Exact identifier application number: M015
Lidocaine	LIDOCAINE	YYBA Corp	5256a84a-8dac-8fd4-e063-6294a90a616c	2026-04-01	Warnings	Exact identifier application number: M015
Hemorrhoidal	LIDOCAINE, MINERAL OIL, PHENYLEPHRINE HCL, WHITE PETROLATUM	Walgreens Co	3d213ba8-3cbe-11c4-e063-6394a90ae016	2026-03-30	Warnings	Exact identifier application number: M015
Critic Aid Skin	ZINC OXIDE	Coloplast Corp	caaac1f0-437d-4185-8670-9f11b9cefe63	2026-03-30	Warnings	Exact identifier application number: M015
CVS Topical Analgesic Hemorrhoidal	DIBUCAINE	CVS PHARMACY,INC	b9e20531-3444-4955-b1d3-bb112340d230	2026-03-27	Warnings	Exact identifier application number: M015
Walgreens Moisture Barrier	WALGREENS MOISTURE BARRIER	Walgreens	44fc098c-1f5f-bf82-e063-6294a90a1405	2026-03-25	Warnings	Exact identifier application number: M015
Lidocaine	LIDOCAINE	YYBA Corp	472fe0d1-31a1-fded-e063-6394a90a4a66	2026-03-25	Warnings	Exact identifier application number: M015
Hemorrhoid Relief Cream	LIDOCAINE 5% ANORECTAL	ALAINA HEALTHCARE PRIVATE LIMITED	53b2c3b0-d729-44d6-bc64-a9e1c9351877	2026-03-23	Warnings	Exact identifier application number: M015
LIDOCAINE	LIDOCAINE	YYBA Corp	4db609cc-f329-62a4-e063-6394a90aefc1	2026-03-23	Warnings	Exact identifier application number: M015
Topical Hemorrhoid Relief Gel	MENTHOL, UNSPECIFIED FORM	Yantai Aien Biotechnology Co., Ltd.	4d6e6667-ab1c-de7c-e063-6294a90a0b9b	2026-03-20	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