Simply Firm - Body

Product NDC: 51439-003
11-digit product format: 514390003
Labeler code: 51439
Product ID: 51439-003_1ad3a24f-b2cb-4189-aa4c-b4670bc8d657
Type: HUMAN OTC DRUG
Nonproprietary name: Dimethicone
Dosage form: GEL
Route: TOPICAL
Labeler: CarePluss Pharma S.A. de C.V.
Application: part347
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2012-08-05
Marketing end: 0000-00-00
Substance: DIMETHICONE
Active strength: 0 mg/.024mg
NDC exclude flag: E
Listing certified through: 2017-12-31
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	51439-003		I	Inactivated by FDA		2026-10-05
excluded package	package	51439-003	51439-003-01	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 · 44 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	51439-003-01	`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	51439-003-01	`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	51439-003-01	`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	51439-003-01	`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	51439-003-01	`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	51439-003-01	`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	51439-003-01	`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	51439-003-01	`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	51439-003-01	`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	51439-003-01	`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	51439-003-01	`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	51439-003-01	`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	51439-003-01	`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	51439-003-01	`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	51439-003-01	`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	51439-003-01	`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	51439-003-01	`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	51439-003-01	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	51439-003-01	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	51439-003-01	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	51439-003-01	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	51439-003-01	`110d247fa046…`	`a55b01930146…`

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
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508
08c722ec-780f-bb7b-8f14-3d4f7bf0e098	Product name	2	20240205
e2f276e5-439f-b432-b5e5-b0cfa993da69	Product name	3	20220609
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122
4585a4fb-0028-3d95-020c-9b1c40bf15e0	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51439-003-01	2019-11-27	C162847	48780-1	9855d018-e0d2-cd31-e053-dbdaa90ab51a	3259fef2-b2e2-40aa-b383-601d65e982c4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51439-003-01	Simply Firm - BodyGelcreme	.024 mg in 1 TUBE	GEL	.024		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Dimethicone	ACTIVE INGREDIENT	92RU3N3Y1O	SIMPLY FIRM - BODY GELCREME (DIMETHICONE) GEL [CAREPLUSS PHARMA S.A. DE C.V.]	4
Dimethicone	ACTIVE MOIETY	92RU3N3Y1O	SIMPLY FIRM - BODY GELCREME (DIMETHICONE) GEL [CAREPLUSS PHARMA S.A. DE C.V.]	4
ALMOND	INACTIVE INGREDIENT	3Z252A2K9G	SIMPLY FIRM - BODY GELCREME (DIMETHICONE) GEL [CAREPLUSS PHARMA S.A. DE C.V.]	4
ALMOND OIL	INACTIVE INGREDIENT	66YXD4DKO9	SIMPLY FIRM - BODY GELCREME (DIMETHICONE) GEL [CAREPLUSS PHARMA S.A. DE C.V.]	4
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMPLY FIRM - BODY GELCREME (DIMETHICONE) GEL [CAREPLUSS PHARMA S.A. DE C.V.]	4
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMPLY FIRM - BODY GELCREME (DIMETHICONE) GEL [CAREPLUSS PHARMA S.A. DE C.V.]	4
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	SIMPLY FIRM - BODY GELCREME (DIMETHICONE) GEL [CAREPLUSS PHARMA S.A. DE C.V.]	4
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	71DD5V995L	SIMPLY FIRM - BODY GELCREME (DIMETHICONE) GEL [CAREPLUSS PHARMA S.A. DE C.V.]	4
CETEARETH-12	INACTIVE INGREDIENT	7V4MR24V5P	SIMPLY FIRM - BODY GELCREME (DIMETHICONE) GEL [CAREPLUSS PHARMA S.A. DE C.V.]	4
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	SIMPLY FIRM - BODY GELCREME (DIMETHICONE) GEL [CAREPLUSS PHARMA S.A. DE C.V.]	4
DEANOL	INACTIVE INGREDIENT	2N6K9DRA24	SIMPLY FIRM - BODY GELCREME (DIMETHICONE) GEL [CAREPLUSS PHARMA S.A. DE C.V.]	4
EDETIC ACID	INACTIVE INGREDIENT	9G34HU7RV0	SIMPLY FIRM - BODY GELCREME (DIMETHICONE) GEL [CAREPLUSS PHARMA S.A. DE C.V.]	4
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	SIMPLY FIRM - BODY GELCREME (DIMETHICONE) GEL [CAREPLUSS PHARMA S.A. DE C.V.]	4
GREEN TEA LEAF	INACTIVE INGREDIENT	W2ZU1RY8B0	SIMPLY FIRM - BODY GELCREME (DIMETHICONE) GEL [CAREPLUSS PHARMA S.A. DE C.V.]	4
LEVOCARNITINE	INACTIVE INGREDIENT	0G389FZZ9M	SIMPLY FIRM - BODY GELCREME (DIMETHICONE) GEL [CAREPLUSS PHARMA S.A. DE C.V.]	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	SIMPLY FIRM - BODY GELCREME (DIMETHICONE) GEL [CAREPLUSS PHARMA S.A. DE C.V.]	4
MINT	INACTIVE INGREDIENT	FV98Z8GITP	SIMPLY FIRM - BODY GELCREME (DIMETHICONE) GEL [CAREPLUSS PHARMA S.A. DE C.V.]	4
PEPPERMINT OIL	INACTIVE INGREDIENT	AV092KU4JH	SIMPLY FIRM - BODY GELCREME (DIMETHICONE) GEL [CAREPLUSS PHARMA S.A. DE C.V.]	4
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	SIMPLY FIRM - BODY GELCREME (DIMETHICONE) GEL [CAREPLUSS PHARMA S.A. DE C.V.]	4
SODIUM ASCORBYL PHOSPHATE	INACTIVE INGREDIENT	836SJG51DR	SIMPLY FIRM - BODY GELCREME (DIMETHICONE) GEL [CAREPLUSS PHARMA S.A. DE C.V.]	4
SODIUM DODECYLBENZENESULFONATE	INACTIVE INGREDIENT	554127163Y	SIMPLY FIRM - BODY GELCREME (DIMETHICONE) GEL [CAREPLUSS PHARMA S.A. DE C.V.]	4
SUNFLOWER OIL	INACTIVE INGREDIENT	3W1JG795YI	SIMPLY FIRM - BODY GELCREME (DIMETHICONE) GEL [CAREPLUSS PHARMA S.A. DE C.V.]	4
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	SIMPLY FIRM - BODY GELCREME (DIMETHICONE) GEL [CAREPLUSS PHARMA S.A. DE C.V.]	4
Water	INACTIVE INGREDIENT	059QF0KO0R	SIMPLY FIRM - BODY GELCREME (DIMETHICONE) GEL [CAREPLUSS PHARMA S.A. DE C.V.]	4
WEST INDIAN LEMONGRASS OIL	INACTIVE INGREDIENT	5BIA40E9ED	SIMPLY FIRM - BODY GELCREME (DIMETHICONE) GEL [CAREPLUSS PHARMA S.A. DE C.V.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51439-003	SIMPLY FIRM - BODY GELCREME (DIMETHICONE) GEL [CAREPLUSS PHARMA S.A. DE C.V.]	4	Legacy NDC, 1 package rows	20130423_3259fef2-b2e2-40aa-b383-601d65e982c4.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
92RU3N3Y1O	DIMETHICONE	9006-65-9	DIMETHICONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
51439-003-01	51439000301	.024 mg in 1 TUBE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Simply Firm - Body Gelcreme - CarePluss Pharma S.A. de C.V.	CarePluss Pharma S.A. de C.V.	2013-04-23	HUMAN OTC DRUG LABEL	4