Coolbottoms

Product NDC: 50952-001
11-digit product format: 509520001
Labeler code: 50952
Product ID: 50952-001_cadd20c2-a235-431a-b13b-13fbc102e6cf
Type: HUMAN OTC DRUG
Nonproprietary name: Dimethicone
Dosage form: CREAM
Route: TOPICAL
Labeler: pH R&D LLC
Application: part347
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2010-04-25
Marketing end: 0000-00-00
Substance: DIMETHICONE
Active strength: 1 g/57g
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 · 8 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50952-001		I	Inactivated by FDA	2026-10-16
excluded package	package	50952-001	50952-001-01	I	Inactivated by FDA	2026-10-16
excluded package	package	50952-001	50952-001-02	I	Inactivated by FDA	2026-10-16
excluded package	package	50952-001	50952-001-03	I	Inactivated by FDA	2026-10-16
excluded package	package	50952-001	50952-001-04	I	Inactivated by FDA	2026-10-16
excluded package	package	50952-001	50952-001-05	I	Inactivated by FDA	2026-10-16
excluded package	package	50952-001	50952-001-06	I	Inactivated by FDA	2026-10-16
excluded package	package	50952-001	50952-001-07	I	Inactivated by FDA	2026-10-16

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 3 · 176 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	50952-001-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50952-001-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50952-001-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50952-001-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50952-001-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50952-001-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50952-001-04	`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	50952-001-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50952-001-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50952-001-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50952-001-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50952-001-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50952-001-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50952-001-04	`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	50952-001-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50952-001-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50952-001-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50952-001-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50952-001-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50952-001-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50952-001-04	`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	50952-001-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50952-001-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50952-001-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50952-001-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50952-001-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50952-001-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50952-001-04	`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	50952-001-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50952-001-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50952-001-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50952-001-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50952-001-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50952-001-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50952-001-04	`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	50952-001-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50952-001-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50952-001-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50952-001-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50952-001-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50952-001-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50952-001-04	`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	50952-001-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50952-001-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50952-001-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50952-001-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50952-001-07	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50952-001-06	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50952-001-04	`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	50952-001-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50952-001-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50952-001-05	`ed331223b511…`	`672a5bd82f5f…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
50952-001-01	Cool bottoms ® DIAPER RASH CREAM
50952-001-02	Cool bottoms ® DIAPER RASH CREAM
50952-001-03	Cool bottoms ® DIAPER RASH CREAM
50952-001-04	Cool bottoms ® DIAPER RASH CREAM
50952-001-05	Cool bottoms ® DIAPER RASH CREAM
50952-001-06	Cool bottoms ® DIAPER RASH CREAM
50952-001-07	Cool bottoms ® DIAPER RASH CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50952-001-01	Coolbottoms Diaper Rash	57 g in 1 JAR	CREAM	57	2
50952-001-01	Coolbottoms Diaper Rash	1 in 1 BOX	CREAM	1	2
50952-001-02	Coolbottoms Diaper Rash	12 in 1 BOX	CREAM	12	2
50952-001-02	Coolbottoms Diaper Rash	57 g in 1 JAR	CREAM	57	2
50952-001-03	Coolbottoms Diaper Rash	24 in 1 BOX	CREAM	24	2
50952-001-03	Coolbottoms Diaper Rash	57 g in 1 JAR	CREAM	57	2
50952-001-04	Coolbottoms Diaper Rash	28 g in 1 JAR	CREAM	28	2
50952-001-04	Coolbottoms Diaper Rash	4 in 1 BOX	CREAM	4	2
50952-001-05	Coolbottoms Diaper Rash	8 in 1 BOX	CREAM	8	2
50952-001-05	Coolbottoms Diaper Rash	28 g in 1 JAR	CREAM	28	2
50952-001-06	Coolbottoms Diaper Rash	12 in 1 BOX	CREAM	12	2
50952-001-06	Coolbottoms Diaper Rash	28 g in 1 JAR	CREAM	28	2
50952-001-07	Coolbottoms Diaper Rash	28 g in 1 JAR	CREAM	28	2
50952-001-07	Coolbottoms Diaper Rash	24 in 1 BOX	CREAM	24	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50952-001-01	GM - Gram	50952-001	01ec3b6a-17b8-491e-ab60-4bdef3b4d457	1	2012-07-24
50952-001-02	GM - Gram	50952-001	9ad291b2-0dc4-431d-8df5-5ab86d4dbb42	1	2012-07-24
50952-001-03	GM - Gram	50952-001	34b1d14b-1ce2-4ace-98be-0ee4d8914f81	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Dimethicone	ACTIVE INGREDIENT	92RU3N3Y1O	COOLBOTTOMS (DIMETHICONE) CREAM [PH R&D LLC]	2
Dimethicone	ACTIVE MOIETY	92RU3N3Y1O	COOLBOTTOMS (DIMETHICONE) CREAM [PH R&D LLC]	2
Butylated Hydroxytoluene	INACTIVE INGREDIENT	1P9D0Z171K	COOLBOTTOMS (DIMETHICONE) CREAM [PH R&D LLC]	2
Ethylhexylglycerin	INACTIVE INGREDIENT	147D247K3P	COOLBOTTOMS (DIMETHICONE) CREAM [PH R&D LLC]	2
Lanolin Alcohols	INACTIVE INGREDIENT	884C3FA9HE	COOLBOTTOMS (DIMETHICONE) CREAM [PH R&D LLC]	2
Magnesium Hydroxide	INACTIVE INGREDIENT	NBZ3QY004S	COOLBOTTOMS (DIMETHICONE) CREAM [PH R&D LLC]	2
Mineral Oil	INACTIVE INGREDIENT	T5L8T28FGP	COOLBOTTOMS (DIMETHICONE) CREAM [PH R&D LLC]	2
Petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	COOLBOTTOMS (DIMETHICONE) CREAM [PH R&D LLC]	2
Phenoxyethanol	INACTIVE INGREDIENT	HIE492ZZ3T	COOLBOTTOMS (DIMETHICONE) CREAM [PH R&D LLC]	2
Sorbitan Sesquioleate	INACTIVE INGREDIENT	0W8RRI5W5A	COOLBOTTOMS (DIMETHICONE) CREAM [PH R&D LLC]	2
Sorbitol	INACTIVE INGREDIENT	506T60A25R	COOLBOTTOMS (DIMETHICONE) CREAM [PH R&D LLC]	2
Water	INACTIVE INGREDIENT	059QF0KO0R	COOLBOTTOMS (DIMETHICONE) CREAM [PH R&D LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50952-001	COOLBOTTOMS (DIMETHICONE) CREAM [PH R&D LLC]	2	Legacy NDC, 14 package rows	20110113_38fcc371-0eab-46e1-a98a-3784e12aa9af.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1044936	Cool bottoms 1 % Topical Cream	PSN	38fcc371-0eab-46e1-a98a-3784e12aa9af	2
200010	dimethicone 1 % Topical Cream	PSN	38fcc371-0eab-46e1-a98a-3784e12aa9af	2
1044936	dimethicone 10 MG/ML Topical Cream [Cool bottoms]	SBD	38fcc371-0eab-46e1-a98a-3784e12aa9af	2
200010	dimethicone 10 MG/ML Topical Cream	SCD	38fcc371-0eab-46e1-a98a-3784e12aa9af	2
1044936	Cool bottoms 1 % Topical Cream	SY	38fcc371-0eab-46e1-a98a-3784e12aa9af	2
1044936	Cool bottoms 10 MG/ML Topical Cream	SY	38fcc371-0eab-46e1-a98a-3784e12aa9af	2
200010	dimethicone 1 % Topical Cream	SY	38fcc371-0eab-46e1-a98a-3784e12aa9af	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
50952-001-01	50952000101	57 g in 1 JAR	57 g	Historical
50952-001-02	50952000102	12 in 1 BOX		Historical
50952-001-03	50952000103	24 in 1 BOX		Historical
50952-001-04	50952000104	28 g in 1 JAR	28 g	Historical
50952-001-05	50952000105	8 in 1 BOX		Historical
50952-001-06	50952000106	12 in 1 BOX		Historical
50952-001-07	50952000107	28 g in 1 JAR	28 g	Historical