Selenium Sulfide Topical Suspension USP, 2.5% (Lotion)

Manufacturer: Padagis Israel Pharmaceuticals Ltd
Effective date: 2025-05-31
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 8
Source: full-release
Hydrated at: 2026-05-31 22:02:21

Label at a glance#

ProductSELENIUM SULFIDE

Active ingredientSELENIUM SULFIDE

Label structure16 sections

Indications and uses

For the treatment of tinea versicolor, seborrheic dermatitis of the scalp, and dandruff.

Dosage and administration

See application instructions on rear panel of this bottle. For treatment of dandruff and seborrheic dermatitis: For the usual case, two applications each week for two weeks will afford control. After this, the suspension may be used at less frequent intervals - weekly, every two weeks, or even every 3 or 4 weeks in some cases. The preparation should not be applied more frequently than required to maintain control....

Storage and handling

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Contacts and useful links#

Websitewww.padagis.com

www.padagis.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

For External Use Only

Shake Well Before Use

Rx Only

APPLICATION INSTRUCTIONS

SPL UNCLASSIFIED SECTION

Keep tightly capped. SHAKE WELL BEFORE USING.

Product may damage jewelry; remove jewelry before use.

For treatment of dandruff and seborrheic dermatitis of the scalp:

1. Massage about 1 or 2 teaspoonsful of suspension into wet scalp.

2. Allow to remain on scalp for 2 to 3 minutes.

3. Rinse scalp thoroughly.

4. Repeat application and rinse thoroughly.

5. After treatment, wash hands well.

6. Repeat treatments as directed by physician.

For treatment of tinea versicolor:

1. Apply to affected areas and lather with a small amount of water.

2. Allow to remain on skin for 10 minutes.

3. Rinse body thoroughly.

4. Repeat this procedure once a day for seven days.

DESCRIPTION

DESCRIPTION SECTION

A liquid antiseborrheic, antifungal preparation for topical application. Selenium sulfide has the molecular formula SeS₂ and has a molecular weight of 143.09.

CONTAINS:

SPL UNCLASSIFIED SECTION

Selenium sulfide 2.5%; bentonite, citric acid, cocoamphocarboxyglycinate, ethylene glycol monostearate, fragrance, glycerol monoricinoleate, lauramide DEA, sodium lauryl sulfate, sodium phosphate (monobasic), titanium dioxide, and water.

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

Selenium sulfide appears to have a cytostatic effect on cells of the epidermis and follicular epithelium, thus reducing corneocyte production.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

For the treatment of tinea versicolor, seborrheic dermatitis of the scalp, and dandruff.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

This product should not be used by patients allergic to any of its components.

PRECAUTIONS

PRECAUTIONS SECTION

General -

GENERAL PRECAUTIONS SECTION

Should not be used when acute inflammation or exudation is present as increased absorption may occur.

Information for Patients -

INFORMATION FOR PATIENTS SECTION

Application to skin or scalp may produce skin irritation or sensitization. If sensitivity reactions occur, use should be discontinued. May be irritating to mucous membranes of the eyes and contact with this area should be avoided. When applied to the body for treatment of tinea versicolor, Selenium Sulfide Topical Suspension USP, 2.5% (Lotion) may produce skin irritation especially in the genital area and where skin folds occur. These areas should be thoroughly rinsed after application.

Carcinogenesis -

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

Studies in mice using dermal application of 25% and 50% solutions of 2.5% selenium sulfide topical suspension, over an 88 week period, indicated no carcinogenic effects.

Pregnancy -

PREGNANCY SECTION

WHEN USED ON BODY SURFACES FOR THE TREATMENT OF TINEA VERSICOLOR, SELENIUM SULFIDE IS CLASSIFIED AS PREGNANCY CATEGORY "C". Animal reproduction studies have not been conducted with Selenium Sulfide Topical Suspension USP, 2.5% (Lotion). It is also not known whether Selenium Sulfide Topical Suspension USP, 2.5% (Lotion) can cause fetal harm when applied to body surfaces of a pregnant woman or can affect reproduction capacity. Under ordinary circumstances Selenium Sulfide Topical Suspension USP, 2.5% (Lotion) should not be used for the treatment of tinea versicolor in pregnant women.

Pediatric Use -

PEDIATRIC USE SECTION

Safety and effectiveness in infants have not been established.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

In decreasing order of severity: skin irritation, occasional reports of increase in amount of normal hair loss, discoloration of hair (can be avoided or minimized by thorough rinsing of hair after treatment). As with other shampoos, oiliness or dryness of hair and scalp may occur.

OVERDOSAGE

OVERDOSAGE SECTION

Accidental Oral Ingestion-

SPL UNCLASSIFIED SECTION

Selenium Sulfide Topical Suspension USP, 2.5% (Lotion) is intended for external use only. There have been no documented reports of serious toxicity in humans resulting from acute ingestion of Selenium Sulfide Topical Suspension USP, 2.5% (Lotion); however, acute toxicity studies in animals suggest that ingestion of large amounts could result in potential human toxicity. For this reason, evacuation of the stomach contents should be considered in cases of acute oral ingestion.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

For treatment of tinea versicolor: Apply to affected areas and lather with a small amount of water. Allow product to remain on skin for 10 minutes, then rinse the body thoroughly. Repeat this procedure once a day for seven days.

HOW SUPPLIED

HOW SUPPLIED SECTION

Selenium Sulfide Topical Suspension USP, 2.5% (Lotion) is available as follows:

4 fl oz plastic bottle (NDC 45802-040-64).

WARNINGS AND PRECAUTIONS:

WARNINGS AND PRECAUTIONS SECTION

For External Use Only. Do not use on broken skin or inflamed areas. If allergic reactions occur, discontinue use. Avoid getting shampoo in eyes or in contact with genital area as it may cause irritation and burning.

KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN.

STORAGE AND HANDLING SECTION

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

SPL UNCLASSIFIED SECTION

Manufactured by Padagis, Minneapolis, MN 55427

www.padagis.com

Rev 05-25

27G26 RC F2/27G26 RC B2

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 45802-040-64

Rx Only

Selenium Sulfide Topical Suspension USP, 2.5% (Lotion)

For External Use Only

Shake Well Before Use

4 FL OZ

Peel Here

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Data code	Data Matrix	27G26RCF2		label.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45802-040-64	SELENIUM SULFIDE	118 mL in 1 BOTTLE	LOTION	118		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45802-040-64	ML - Milliliter	45802-040	6af7df0a-b6f8-44b9-a00d-990f4651fe36	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
SELENIUM SULFIDE	ACTIVE INGREDIENT	Z69D9E381Q	3
SELENIUM SULFIDE	ACTIVE MOIETY	Z69D9E381Q	3
BENTONITE	INACTIVE INGREDIENT	A3N5ZCN45C	3
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	3
GLYCOL STEARATE	INACTIVE INGREDIENT	0324G66D0E	3
LAURIC DIETHANOLAMIDE	INACTIVE INGREDIENT	I29I2VHG38	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	3
SODIUM PHOSPHATE, MONOBASIC	INACTIVE INGREDIENT	3980JIH2SW	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

SELENIUM SULFIDE
BENTONITE
CITRIC ACID MONOHYDRATE
GLYCOL STEARATE
LAURIC DIETHANOLAMIDE
SODIUM LAURYL SULFATE
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM
TITANIUM DIOXIDE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
45802-040	45802-040-64

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SELENIUM SULFIDE	Z69D9E381Q	ACTIB
BENTONITE	A3N5ZCN45C	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
GLYCOL STEARATE	0324G66D0E	IACT
LAURIC DIETHANOLAMIDE	I29I2VHG38	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM	3980JIH2SW	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
7	2021-12-31	full-release	2026-05-31 20:47:16

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 16 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
GLYCOL STEARATE	GLYCOL STEARATE	0324G66D0E	SHAMPOO, SUSPENSION / TOPICAL	5 %w/w		Exact identifier — unii+route 4 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	LOTION / TOPICAL	0.85 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	LOTION / TOPICAL		111 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
GLYCOL STEARATE	GLYCOL STEARATE	0324G66D0E	CREAM / TOPICAL	1 %w/w		Exact identifier — unii+route 4 equally ranked IID candidates
LAURIC DIETHANOLAMIDE	LAURIC DIETHANOLAMIDE	I29I2VHG38	LOTION / TOPICAL	0.6 %w/v		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	SYSTEM / TOPICAL	14.2 mg		Exact identifier — unii+route 2 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	LOTION / TOPICAL	NA		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	LOTION / TOPICAL		111 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
GLYCOL STEARATE	GLYCOL STEARATE	0324G66D0E	CREAM / TOPICAL	1 %w/w		Exact identifier — unii+route 4 equally ranked IID candidates
LAURIC DIETHANOLAMIDE	LAURIC DIETHANOLAMIDE	I29I2VHG38	LOTION / TOPICAL	0.6 %w/v		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	LOTION / TOPICAL	0.85 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	LOTION / TOPICAL	NA		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	LOTION / TOPICAL	5 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	SYSTEM / TOPICAL	14.2 mg		Exact identifier — unii+route 2 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	LOTION / TOPICAL	5 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
GLYCOL STEARATE	GLYCOL STEARATE	0324G66D0E	SHAMPOO, SUSPENSION / TOPICAL	5 %w/w		Exact identifier — unii+route 4 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A089996-001	SELENIUM SULFIDE	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		RS	1991-01-10

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A089996-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		RS	1991-01-10	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A089996-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		RS	1991-01-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A089996-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		RS	1991-01-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A089996-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		RS	1991-01-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089996-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		RS	1991-01-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089996-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		RS	1991-01-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089996-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		RS	1991-01-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089996-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		RS	1991-01-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089996-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		RS	1991-01-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089996-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		RS	1991-01-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089996-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		RS	1991-01-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089996-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		RS	1991-01-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089996-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		RS	1991-01-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089996-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		RS	1991-01-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089996-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		RS	1991-01-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089996-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		RS	1991-01-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089996-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		RS	1991-01-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089996-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	AT	RS	1991-01-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089996-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	AT	RS	1991-01-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089996-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	AT	RS	1991-01-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089996-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	AT	RS	1991-01-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089996-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	AT	RS	1991-01-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089996-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	AT	RS	1991-01-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089996-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	AT	RS	1991-01-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089996-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	AT	RS	1991-01-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089996-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	AT	RS	1991-01-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089996-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	AT	RS	1991-01-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089996-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	AT	RS	1991-01-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089996-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	AT	RS	1991-01-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089996-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	AT	RS	1991-01-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089996-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		RS	1991-01-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089996-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		RS	1991-01-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089996-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		RS	1991-01-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089996-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		RS	1991-01-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089996-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		RS	1991-01-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089996-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		RS	1991-01-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089996-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		RS	1991-01-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089996-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		RS	1991-01-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089996-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		RS	1991-01-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089996-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		RS	1991-01-10	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089996-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089996-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089996-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089996-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089996-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089996-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089996-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089996-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089996-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089996-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089996-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089996-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089996-001	AT	1	`ea99ee380514…`

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SELENIUM SULFIDE	SELENIUM SULFIDE	Padagis Israel Pharmaceuticals Ltd	28b84e3c-ae44-40bb-93c4-2625e19f7e61	2025-05-31	Warnings, Adverse reactions	Exact identifier ndc (package): 45802-040-64 ndc (product): 45802-040 ndc11 (package): 45802004064 spl id: 88f77de3-64b1-4ef8-9b6f-39c54ba9f9e4 spl set id: 28b84e3c-ae44-40bb-93c4-2625e19f7e61

Reported adverse events (FAERS/openFDA)#

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