Halog

Product NDC: 10631-094
11-digit product format: 106310094
Labeler code: 10631
Product ID: 10631-094_40cc929a-926f-4de0-871f-6d6395e6e28c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Halcinonide Cream
Dosage form: CREAM
Route: TOPICAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: NDA017556
Marketing category: NDA
Marketing start: 2009-02-10
Substance: HALCINONIDE
Active strength: 1 mg/g
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N017556-001	HALOG	HALCINONIDE	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N017556-001	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.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	N017556-001	HALOG	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017556-001	HALOG	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017556-001	HALOG	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017556-001	HALOG	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017556-001	HALOG	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017556-001	HALOG	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017556-001	HALOG	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017556-001	HALOG	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017556-001	HALOG	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017556-001	HALOG	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017556-001	HALOG	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017556-001	HALOG	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017556-001	HALOG	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017556-001	HALOG	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017556-001	HALOG	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017556-001	HALOG	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017556-001	HALOG	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017556-001	HALOG	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017556-001	HALOG	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017556-001	HALOG	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017556-001	HALOG	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017556-001	HALOG	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017556-001	HALOG	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017556-001	HALOG	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017556-001	HALOG	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017556-001	HALOG	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017556-001	HALOG	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017556-001	HALOG	0.1%	CREAM / TOPICAL		RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017556-001	HALOG	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017556-001	HALOG	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017556-001	HALOG	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017556-001	HALOG	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017556-001	HALOG	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017556-001	HALOG	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017556-001	HALOG	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017556-001	HALOG	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017556-001	HALOG	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017556-001	HALOG	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017556-001	HALOG	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017556-001	HALOG	0.1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N017556-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017556-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017556-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017556-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017556-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017556-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017556-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017556-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017556-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017556-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017556-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017556-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017556-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017556-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017556-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017556-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017556-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017556-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017556-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017556-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017556-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017556-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017556-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017556-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017556-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017556-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017556-001	AB	1	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017556-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017556-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017556-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017556-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017556-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017556-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017556-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017556-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017556-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017556-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017556-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017556-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017556-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Halog
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HALCINONIDE	1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SI86V6QNEG	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
103467	Internal RxNorm lookup
206546	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
e60d0691-0628-4c98-9a17-f4a89822baf2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
37520c8a-9139-9e9d-9bd5-8abdb9be6b07	Product name	3	20220311
8582553f-f57a-db33-d781-0d1306d11142	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
10631-094-20	Halog	1 in 1 CARTON	CREAM	1	7
10631-094-20	Halog	30 g in 1 TUBE	CREAM	30	7
10631-094-30	Halog	60 g in 1 TUBE	CREAM	60	7
10631-094-30	Halog	1 in 1 CARTON	CREAM	1	7
10631-094-71	Halog	4 in 1 CARTON	CREAM	4	7
10631-094-71	Halog	60 g in 1 TUBE	CREAM	60	7
10631-094-76	Halog	216 g in 1 JAR	CREAM	216	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10631-094-20	GM - Gram	10631-094	cd1c2696-7632-401e-849e-f22186745f1b	1	2012-07-24
10631-094-30	GM - Gram	10631-094	c107c1f5-bbc7-4764-a836-f42095f2d8ce	1	2012-07-24
10631-094-71	GM - Gram	10631-094	ce9ba261-37a0-4a31-9c81-ffb14c4ace5e	1	2018-08-13
10631-094-76	GM - Gram	10631-094	afb2f2a7-e55e-43f0-a1e2-67f986ddf259	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HALCINONIDE	ACTIVE INGREDIENT	SI86V6QNEG	HALOG (HALCINONIDE CREAM) CREAM [RANBAXY LABORATORIES INC]	4
HALCINONIDE	ACTIVE MOIETY	SI86V6QNEG	HALOG (HALCINONIDE CREAM) CREAM [RANBAXY LABORATORIES INC]	4
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	HALOG (HALCINONIDE CREAM) CREAM [RANBAXY LABORATORIES INC]	4
DIMETHICONE 350	INACTIVE INGREDIENT	2Y53S6ATLU	HALOG (HALCINONIDE CREAM) CREAM [RANBAXY LABORATORIES INC]	4
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	HALOG (HALCINONIDE CREAM) CREAM [RANBAXY LABORATORIES INC]	4
ISOPROPYL PALMITATE	INACTIVE INGREDIENT	8CRQ2TH63M	HALOG (HALCINONIDE CREAM) CREAM [RANBAXY LABORATORIES INC]	4
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	HALOG (HALCINONIDE CREAM) CREAM [RANBAXY LABORATORIES INC]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HALOG (HALCINONIDE CREAM) CREAM [RANBAXY LABORATORIES INC]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HALOG (HALCINONIDE CREAM) CREAM [RANBAXY LABORATORIES INC]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	HALOG (HALCINONIDE CREAM) CREAM [RANBAXY LABORATORIES INC]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10631-094	HALOG (HALCINONIDE CREAM) CREAM [SUN PHARMACEUTICAL INDUSTRIES, INC.]	7	Current NDC, Legacy NDC, 7 package rows	20190110_e60d0691-0628-4c98-9a17-f4a89822baf2.zip

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Halog	HALCINONIDE CREAM	Genus Lifesciences Inc.	484c3224-edd1-db3e-e063-6294a90abc25	2026-01-15	Adverse reactions	Exact identifier application applno (NDA): 017556 application number: NDA017556
HALCINONIDE	HALCINONIDE	Sun Pharmaceutical Industries, Inc.	aed461bb-e49e-44c4-b42f-b5b261c072a0	2025-10-15	Adverse reactions	Exact identifier application applno (NDA): 017556 application number: NDA017556
Halog	HALCINONIDE CREAM	Sun Pharmaceutical Industries, Inc.	e60d0691-0628-4c98-9a17-f4a89822baf2	2019-01-07	Adverse reactions	Exact identifier application applno (NDA): 017556 application number: NDA017556 ndc (product): 10631-094

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SI86V6QNEG	HALCINONIDE	3093-35-4	HALCINONIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
103467	halcinonide 0.1 % Topical Cream	PSN	e60d0691-0628-4c98-9a17-f4a89822baf2	7
206546	Halog 0.1 % Topical Cream	PSN	e60d0691-0628-4c98-9a17-f4a89822baf2	7
206546	halcinonide 1 MG/ML Topical Cream [Halog]	SBD	e60d0691-0628-4c98-9a17-f4a89822baf2	7
103467	halcinonide 1 MG/ML Topical Cream	SCD	e60d0691-0628-4c98-9a17-f4a89822baf2	7
103467	halcinonide 0.1 % Topical Cream	SY	e60d0691-0628-4c98-9a17-f4a89822baf2	7
206546	Halog 0.1 % Topical Cream	SY	e60d0691-0628-4c98-9a17-f4a89822baf2	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
10631-094-20	10631009420	1 TUBE in 1 CARTON (10631-094-20) / 30 g in 1 TUBE	1 tube	2009-02-10	0000-00-00	No	No	Current
10631-094-30	10631009430	1 TUBE in 1 CARTON (10631-094-30) / 60 g in 1 TUBE	1 tube	2009-02-10	0000-00-00	No	No	Current
10631-094-71	10631009471	4 TUBE in 1 CARTON (10631-094-71) / 60 g in 1 TUBE	4 tube	2018-07-02	0000-00-00	No	No	Current
10631-094-76	10631009476	216 g in 1 JAR (10631-094-76)	216 g	2009-02-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HALOG ® (Halcinonide Cream, USP) 0.1%	Sun Pharmaceutical Industries, Inc. \| Farmabios S.p.A. \| DPT Laboratories, Ltd	2019-01-07	HUMAN PRESCRIPTION DRUG LABEL	7