MIRACTIL

Product NDC: 69492-011
11-digit product format: 694920011
Labeler code: 69492
Product ID: 69492-011_859e65fa-f696-4e4c-bec2-cecb40038b2a
Type: HUMAN OTC DRUG
Nonproprietary name: Hemorrhoidal Cream
Dosage form: GEL
Route: TOPICAL
Labeler: POLIMEROS Y SERVICIOS S.A-
Application: part346
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2015-05-20
Marketing end: 0000-00-00
Substance: COCOA BUTTER; GLYCERIN; MENTHOL; PETROLATUM; ZINC OXIDE
Active strength: 125 mg/g; mg/g; mg/g; mg/g; mg/g
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	69492-011		I	Inactivated by FDA		2026-10-05
excluded package	package	69492-011	69492-011-06	I	Inactivated by FDA		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69492-011-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69492-011-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69492-011-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69492-011-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69492-011-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69492-011-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69492-011-06	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69492-011-06	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69492-011-06	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69492-011-06	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69492-011-06	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69492-011-06	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69492-011-06	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69492-011-06	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69492-011-06	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	69492-011-06	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	69492-011-06	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	69492-011-06	`bd6a592717d7…`	`303034d00443…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69492-011-06	2022-01-28	C162847	48780-1	d6a99b39-3599-a426-e053-dadaa90af4c2	Submission for Miractil Hemorrhoidal Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69492-011-06	MIRACTIL	30 g in 1 TUBE	GEL	30		4
69492-011-06	MIRACTIL	1 in 1 BOX	GEL	1		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
COCOA BUTTER	ACTIVE INGREDIENT	512OYT1CRR	MIRACTIL (HEMORRHOIDAL CREAM) GEL [POLIMEROS Y SERVICIOS S.A-]	2
GLYCERIN	ACTIVE INGREDIENT	PDC6A3C0OX	MIRACTIL (HEMORRHOIDAL CREAM) GEL [POLIMEROS Y SERVICIOS S.A-]	2
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	MIRACTIL (HEMORRHOIDAL CREAM) GEL [POLIMEROS Y SERVICIOS S.A-]	2
PETROLATUM	ACTIVE INGREDIENT	4T6H12BN9U	MIRACTIL (HEMORRHOIDAL CREAM) GEL [POLIMEROS Y SERVICIOS S.A-]	2
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	MIRACTIL (HEMORRHOIDAL CREAM) GEL [POLIMEROS Y SERVICIOS S.A-]	2
COCOA BUTTER	ACTIVE MOIETY	512OYT1CRR	MIRACTIL (HEMORRHOIDAL CREAM) GEL [POLIMEROS Y SERVICIOS S.A-]	2
GLYCERIN	ACTIVE MOIETY	PDC6A3C0OX	MIRACTIL (HEMORRHOIDAL CREAM) GEL [POLIMEROS Y SERVICIOS S.A-]	2
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	MIRACTIL (HEMORRHOIDAL CREAM) GEL [POLIMEROS Y SERVICIOS S.A-]	2
PETROLATUM	ACTIVE MOIETY	4T6H12BN9U	MIRACTIL (HEMORRHOIDAL CREAM) GEL [POLIMEROS Y SERVICIOS S.A-]	2
ZINC CATION	ACTIVE MOIETY	13S1S8SF37	MIRACTIL (HEMORRHOIDAL CREAM) GEL [POLIMEROS Y SERVICIOS S.A-]	2
CARBOMER 940	INACTIVE INGREDIENT	4Q93RCW27E	MIRACTIL (HEMORRHOIDAL CREAM) GEL [POLIMEROS Y SERVICIOS S.A-]	2
CHITOSAN MEDIUM MOLECULAR WEIGHT (200-400 MPA.S)	INACTIVE INGREDIENT	5GV09YMO52	MIRACTIL (HEMORRHOIDAL CREAM) GEL [POLIMEROS Y SERVICIOS S.A-]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	MIRACTIL (HEMORRHOIDAL CREAM) GEL [POLIMEROS Y SERVICIOS S.A-]	2
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	MIRACTIL (HEMORRHOIDAL CREAM) GEL [POLIMEROS Y SERVICIOS S.A-]	2
ORTHOSILICIC ACID	INACTIVE INGREDIENT	623B93YABH	MIRACTIL (HEMORRHOIDAL CREAM) GEL [POLIMEROS Y SERVICIOS S.A-]	2
POLYCARBOPHIL	INACTIVE INGREDIENT	W25LM17A4W	MIRACTIL (HEMORRHOIDAL CREAM) GEL [POLIMEROS Y SERVICIOS S.A-]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	MIRACTIL (HEMORRHOIDAL CREAM) GEL [POLIMEROS Y SERVICIOS S.A-]	2
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	MIRACTIL (HEMORRHOIDAL CREAM) GEL [POLIMEROS Y SERVICIOS S.A-]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	MIRACTIL (HEMORRHOIDAL CREAM) GEL [POLIMEROS Y SERVICIOS S.A-]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69492-011	MIRACTIL (HEMORRHOIDAL CREAM) GEL [POLIMEROS Y SERVICIOS S.A-]	4	Legacy NDC, 2 package rows	20190306_4b6a4e76-1c37-4163-8a8d-b8a4f926b15b.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
512OYT1CRR	COCOA BUTTER	8002-31-1	COCOA BUTTER
PDC6A3C0OX	GLYCERIN	56-81-5	GLYCERIN
4T6H12BN9U	PETROLATUM	8009-03-8	PETROLATUM
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69492-011-06	69492001106	1 TUBE in 1 BOX (69492-011-06) > 30 g in 1 TUBE	1 tube	2019-03-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Submission for Miractil Hemorrhoidal Cream	POLIMEROS Y SERVICIOS S.A- \| POLIMEROS Y SERVICIOS S.A.	2019-03-05	HUMAN OTC DRUG LABEL	4