REZAMID

Product NDC: 11086-022
11-digit product format: 110860022
Labeler code: 11086
Product ID: 11086-022_c71d00e1-ecc7-7109-e053-2a95a90a6f7e
Type: HUMAN OTC DRUG
Nonproprietary name: SULFUR AND RESORCINOL
Dosage form: LOTION
Route: TOPICAL
Labeler: Summers Laboratories Inc
Application: part333D
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2013-10-30
Marketing end: 0000-00-00
Substance: SULFUR; RESORCINOL
Active strength: 5 g/100mL; 1/100mL
NDC exclude flag: No
Listing certified through: 2022-12-31
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	11086-022		I	Inactivated by FDA		2026-10-12
excluded package	package	11086-022	11086-022-01	I	Inactivated by FDA		2026-10-12

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	11086-022-01	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	11086-022-01	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	11086-022-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	11086-022-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	11086-022-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	11086-022-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	11086-022-01	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	11086-022-01	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	11086-022-01	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2025-01-30	SUMMERS LABS (as PLD) - REZAMID (11086-022)
2025-01-30	Rezamid Acne Lotion (11086-022)
2023-08-05	SUMMERS LABS (as PLD) - REZAMID (11086-022)
2023-08-05	Rezamid Acne Lotion (11086-022)
2023-01-30	SUMMERS LABS (as PLD) - REZAMID (11086-022)
2023-01-30	Rezamid Acne Lotion (11086-022)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
11086-022-01	REZAMID	56.7 mL in 1 BOTTLE	LOTION	56.7		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11086-022-01	GM - Gram	11086-022	c2e65bae-af72-4a4a-a43e-de702c661e4a	1	2013-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
RESORCINOL	ACTIVE INGREDIENT	YUL4LO94HK	REZAMID (SULFUR AND RESORCINOL) LOTION [SUMMERS LABORATORIES INC]	3
SULFUR	ACTIVE INGREDIENT	70FD1KFU70	REZAMID (SULFUR AND RESORCINOL) LOTION [SUMMERS LABORATORIES INC]	3
RESORCINOL	ACTIVE MOIETY	YUL4LO94HK	REZAMID (SULFUR AND RESORCINOL) LOTION [SUMMERS LABORATORIES INC]	3
SULFUR	ACTIVE MOIETY	70FD1KFU70	REZAMID (SULFUR AND RESORCINOL) LOTION [SUMMERS LABORATORIES INC]	3
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	REZAMID (SULFUR AND RESORCINOL) LOTION [SUMMERS LABORATORIES INC]	3
ATTAPULGITE	INACTIVE INGREDIENT	U6V729APAM	REZAMID (SULFUR AND RESORCINOL) LOTION [SUMMERS LABORATORIES INC]	3
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	REZAMID (SULFUR AND RESORCINOL) LOTION [SUMMERS LABORATORIES INC]	3
CHLOROXYLENOL	INACTIVE INGREDIENT	0F32U78V2Q	REZAMID (SULFUR AND RESORCINOL) LOTION [SUMMERS LABORATORIES INC]	3
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	REZAMID (SULFUR AND RESORCINOL) LOTION [SUMMERS LABORATORIES INC]	3
EDETIC ACID	INACTIVE INGREDIENT	9G34HU7RV0	REZAMID (SULFUR AND RESORCINOL) LOTION [SUMMERS LABORATORIES INC]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	REZAMID (SULFUR AND RESORCINOL) LOTION [SUMMERS LABORATORIES INC]	3
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	INACTIVE INGREDIENT	8136Y38GY5	REZAMID (SULFUR AND RESORCINOL) LOTION [SUMMERS LABORATORIES INC]	3
LAURIC DIETHANOLAMIDE	INACTIVE INGREDIENT	I29I2VHG38	REZAMID (SULFUR AND RESORCINOL) LOTION [SUMMERS LABORATORIES INC]	3
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	REZAMID (SULFUR AND RESORCINOL) LOTION [SUMMERS LABORATORIES INC]	3
PEG-8 LAURATE	INACTIVE INGREDIENT	762O8IWA10	REZAMID (SULFUR AND RESORCINOL) LOTION [SUMMERS LABORATORIES INC]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	REZAMID (SULFUR AND RESORCINOL) LOTION [SUMMERS LABORATORIES INC]	3
SILICON	INACTIVE INGREDIENT	Z4152N8IUI	REZAMID (SULFUR AND RESORCINOL) LOTION [SUMMERS LABORATORIES INC]	3
SODIUM BISULFITE	INACTIVE INGREDIENT	TZX5469Z6I	REZAMID (SULFUR AND RESORCINOL) LOTION [SUMMERS LABORATORIES INC]	3
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	REZAMID (SULFUR AND RESORCINOL) LOTION [SUMMERS LABORATORIES INC]	3
SODIUM NAPHTHALENESULFONATE	INACTIVE INGREDIENT	D3F8YRX7TP	REZAMID (SULFUR AND RESORCINOL) LOTION [SUMMERS LABORATORIES INC]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	REZAMID (SULFUR AND RESORCINOL) LOTION [SUMMERS LABORATORIES INC]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	REZAMID (SULFUR AND RESORCINOL) LOTION [SUMMERS LABORATORIES INC]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	REZAMID (SULFUR AND RESORCINOL) LOTION [SUMMERS LABORATORIES INC]	3
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	REZAMID (SULFUR AND RESORCINOL) LOTION [SUMMERS LABORATORIES INC]	3
ZINC OXIDE	INACTIVE INGREDIENT	SOI2LOH54Z	REZAMID (SULFUR AND RESORCINOL) LOTION [SUMMERS LABORATORIES INC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11086-022	REZAMID (SULFUR AND RESORCINOL) LOTION [SUMMERS LABORATORIES INC]	9	Legacy NDC, 1 package rows	20231011_d02ace0b-7244-45d4-987f-eb569303a426.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
70FD1KFU70	SULFUR	7704-34-9	SULFUR
YUL4LO94HK	RESORCINOL	108-46-3	RESORCINOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
212589	Rezamid 5 % / 2 % Topical Lotion	PSN	d02ace0b-7244-45d4-987f-eb569303a426	9
245613	sulfur 5 % / resorcinol 2 % Topical Lotion	PSN	d02ace0b-7244-45d4-987f-eb569303a426	9
212589	resorcinol 20 MG/ML / sulfur 50 MG/ML Topical Lotion [Rezamid]	SBD	d02ace0b-7244-45d4-987f-eb569303a426	9
245613	resorcinol 20 MG/ML / sulfur 50 MG/ML Topical Lotion	SCD	d02ace0b-7244-45d4-987f-eb569303a426	9
245613	resorcinol 2 % / sulfur 5 % Topical Lotion	SY	d02ace0b-7244-45d4-987f-eb569303a426	9
212589	Rezamid (resorcinol 2 % / sulfur 5 % ) Topical Lotion	SY	d02ace0b-7244-45d4-987f-eb569303a426	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11086-022-01	11086002201	56.7 mL in 1 BOTTLE (11086-022-01)	56.7 ml	2013-10-30	0000-00-00	No	No	Current