Dapsone Gel

Manufacturer: Zydus Lifesciences Limited
Effective date: 2024-05-09
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 21:03:18

Label at a glance#

ProductDapsone

Active ingredientDAPSONE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dapsone Gel, 7.5%

60 g

NDC 70771-1538-3

Zydus

Rx only

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1741905	dapsone 7.5 % Topical Gel	PSN	1
1741905	dapsone 0.075 MG/MG Topical Gel	SCD	1
1741905	dapsone 7.5 % Topical Gel	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DAPSONE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4ae3f83f-9ccb-db71-5718-0b1e959868df	Product name	5	20260113
5ae2790a-f798-4a69-8811-64a4723c389a	Product name	5	20250325
b8929bfc-0002-d39a-046d-72ddf714efbe	Product name	6	20190618

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70771-1538-2	Dapsone	1 in 1 CARTON	GEL	1	1
70771-1538-2	Dapsone	30 g in 1 BOTTLE, PUMP	GEL	30	1
70771-1538-3	Dapsone	60 g in 1 BOTTLE, PUMP	GEL	60	1
70771-1538-3	Dapsone	1 in 1 CARTON	GEL	1	1
70771-1538-8	Dapsone	1 in 1 CARTON	GEL	1	1
70771-1538-8	Dapsone	90 g in 1 BOTTLE, PUMP	GEL	90	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1538	DAPSONE GEL [ZYDUS LIFESCIENCES LIMITED]	1	Current NDC, 6 package rows	20240511_8b63b653-0507-4f95-9bfa-70fd071e15a6.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

Dapsone
ACRYLAMIDE
DIETHYLENE GLYCOL MONOETHYL ETHER
ISOHEXADECANE
METHYLPARABEN
POLYSORBATE 80
SODIUM ACRYLOYLDIMETHYLTAURATE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1538	70771-1538-2, 70771-1538-3, 70771-1538-8

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DAPSONE	8W5C518302	ACTIB
ACRYLAMIDE	20R035KLCI	IACT
DIETHYLENE GLYCOL MONOETHYL ETHER	A1A1I8X02B	IACT
ISOHEXADECANE	918X1OUF1E	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
SODIUM ACRYLOYLDIMETHYLTAURATE	2T9Q6EKI0G	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML

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
A214019-001	DAPSONE	DAPSONE	7.5%	GEL / TOPICAL	AB		2024-05-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A214019-001	AB

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A214019-001	DAPSONE	7.5%	GEL / TOPICAL	AB	2024-05-08	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A214019-001	DAPSONE	7.5%	GEL / TOPICAL	AB	2024-05-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214019-001	DAPSONE	7.5%	GEL / TOPICAL	AB	2024-05-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214019-001	DAPSONE	7.5%	GEL / TOPICAL	AB	2024-05-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214019-001	DAPSONE	7.5%	GEL / TOPICAL	AB	2024-05-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214019-001	DAPSONE	7.5%	GEL / TOPICAL	AB	2024-05-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214019-001	DAPSONE	7.5%	GEL / TOPICAL	AB	2024-05-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214019-001	DAPSONE	7.5%	GEL / TOPICAL	AB	2024-05-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214019-001	DAPSONE	7.5%	GEL / TOPICAL	AB	2024-05-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214019-001	DAPSONE	7.5%	GEL / TOPICAL	AB	2024-05-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214019-001	DAPSONE	7.5%	GEL / TOPICAL	AB	2024-05-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214019-001	DAPSONE	7.5%	GEL / TOPICAL	AB	2024-05-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214019-001	DAPSONE	7.5%	GEL / TOPICAL	AB	2024-05-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214019-001	DAPSONE	7.5%	GEL / TOPICAL	AB	2024-05-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214019-001	DAPSONE	7.5%	GEL / TOPICAL	AB	2024-05-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214019-001	DAPSONE	7.5%	GEL / TOPICAL	AB	2024-05-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214019-001	DAPSONE	7.5%	GEL / TOPICAL	AB	2024-05-08	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214019-001	DAPSONE	7.5%	GEL / TOPICAL	AB	2024-05-08	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A214019-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A214019-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214019-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214019-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214019-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214019-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214019-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214019-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214019-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214019-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214019-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214019-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214019-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214019-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214019-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214019-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214019-001	AB	1	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214019-001	AB	1	`a50c72e98297…`

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
Dapsone	DAPSONE	Zydus Lifesciences Limited	8b63b653-0507-4f95-9bfa-70fd071e15a6	2024-05-09		Exact identifier ndc (package): 70771-1538-3 ndc (package): 70771-1538-8 ndc (package): 70771-1538-2 ndc (product): 70771-1538 ndc11 (package): 70771153802 ndc11 (package): 70771153808 ndc11 (package): 70771153803 spl id: ae448df2-611f-4d56-911f-11d01983726f spl set id: 8b63b653-0507-4f95-9bfa-70fd071e15a6

Reported adverse events (FAERS/openFDA)#

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