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
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 1 of 23 · 444 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Flarestop Hemorrhoid Lidocaine	LIDOCAINE	Chelsea Pharmacceuticals LLC	b8a589f7-7131-4807-9bcb-84af3078e258	2026-09-10	Warnings	Exact identifier application number: M015
BCBCYC Numbing Cream	LIDOCAINE 5% NUMBING CREAM	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	5ab36566-ba2f-06ef-e063-6394a90a71b5	2026-09-10	Warnings	Exact identifier application number: M015
5% Lidocaine 10g	5% LIDOCAINE	Chongqing Mandongzi Technology Co., Ltd	5b10530f-47cd-c4bd-e063-6294a90aaa0a	2026-09-09	Warnings	Exact identifier application number: M015
Hemorrhoidal	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM	Rite Aid Corporation	407c78ca-6fee-4ed6-b61b-711ec049c86e	2026-09-09	Warnings	Exact identifier application number: M015
Hemorrhoidal	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM	CVS Pharmacy	3167c918-a7d3-46a1-a85b-64f9c22916f2	2026-09-04	Warnings	Exact identifier application number: M015
Flushable Hemorrhoidal Medicated Wipes Maximum Strength	WITCH HAZEL	Amazon.com Services LLC	41d756f3-e523-ed14-e063-6394a90ab817	2026-09-03	Warnings, Adverse reactions	Exact identifier application number: M015
Signature Care Medicated Wipes Hemorrhoidal Wipes with Witch Hazel	HEMORRHOIDAL WIPES WITH WITCH HAZEL	Better Living Brands LLC	adf26111-70ba-596c-e053-2995a90ac6f1	2026-09-03	Warnings, Adverse reactions	Exact identifier application number: M015
Medicated Wipes Hemorrhoidal Wipes with Witch Hazel	WITCH HAZEL	CVS Pharmacy, Inc.	1fa7131a-8a94-47f4-826e-197a9cc5ec51	2026-09-03	Warnings, Adverse reactions	Exact identifier application number: M015
up and up medicated wipes manixim strength	GENTLE HEMORRHOIDAL CARE	Target Corporation	271eab2b-ed13-39f1-e054-00144ff88e88	2026-09-03	Warnings, Adverse reactions	Exact identifier application number: M015
KROGER MEDICATED WIPES HEMORRHOIDAL WIPE WITH WITCH HAZEL AND ALOE	WITCH HAZEL CLOTH	The Kroger Co.	48c1598d-6667-446f-ac90-10ab945d0617	2026-09-03	Warnings, Adverse reactions	Exact identifier application number: M015
Rexall Medicated WipesHemorrhoidal wipe Hemorrhoidal wipes with witch hazel	WITCH HAZEL	Old East Main Co.	2055289d-962e-46a9-b371-b5bb93dd46b4	2026-09-03	Warnings, Adverse reactions	Exact identifier application number: M015
Equate Hemorrhoidal Medicated Wipes	WITCH HAZEL	Walmart Inc.	8d57f054-77dc-4205-85f1-b65dcfde677b	2026-09-03	Warnings, Adverse reactions	Exact identifier application number: M015
Lidocaine Cream	LIDOCAINE	InvaDerm Corporation	5a7273d1-1dbc-420e-e063-6294a90a8629	2026-09-01	Warnings	Exact identifier application number: M015
Lidocaine Phenylephrine	LIDOCAINE PHENYLEPHRINE	YYBA CORP	5a72a190-2129-411e-e063-6394a90a08c2	2026-09-01	Warnings	Exact identifier application number: M015
INICEI 5% LIDOCAINE Numbing Cream	5% LIDOCAINE NUMBING CREAM	Guangzhou Jingliang Cosmetics Co., Ltd.	5a65842f-27a1-268b-e063-6294a90a6054	2026-08-31	Warnings	Exact identifier application number: M015
AnievaLC	LIDOCAINE	Blackstone Products, LLC	ddaba14c-10de-44e2-ae13-9217e20cb48e	2026-08-29	Warnings	Exact identifier application number: M015
Norms Hemorrhoid Wipes	WITCH HAZEL	Totally Normal Company	5a1af50b-8d00-f589-e063-6394a90af86c	2026-08-28	Warnings	Exact identifier application number: M015
LAIYINHE Numbing Cream Anorectal (Hemorrhoidal) Cream	LIDOCAINE	Guangzhou Hechuang Commercial Service Co.,Ltd.	59f0fa16-5eb0-e6bb-e063-6294a90aacf5	2026-08-26	Warnings	Exact identifier application number: M015
Dude Hemorrhoidal Wipes	WITCH HAZEL	Dude Products	fdf408ef-9392-a812-e053-6394a90a0017	2026-08-25	Warnings	Exact identifier application number: M015
Norms Medicated Wipes	WITCH HAZEL	Totally Normal Company	3a78e109-3f7c-fb19-e063-6394a90ae78e	2026-08-22	Warnings	Exact identifier application number: M015

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

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