BETIMOL

Product NDC: 82584-001
11-digit product format: 825840001
Labeler code: 82584
Product ID: 82584-001_3891d7f3-d858-9f71-e063-6394a90af95b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: timolol
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Thea Pharma Inc.
Application: NDA020439
Marketing category: NDA
Marketing start: 2022-12-01
Substance: TIMOLOL
Active strength: 2.56 mg/mL
Pharmacologic classes: Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	82584-001	82584-001-05	D	Discontinued by firm		2026-08-11

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	82584-001	82584-001-05	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	82584-001	82584-001-05	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020439-001	BETIMOL	TIMOLOL	0.25%	SOLUTION/DROPS / OPHTHALMIC		RLD	1995-03-31
N020439-002	BETIMOL	TIMOLOL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020439-002	AT

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 3 · 82 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
2026-02-19 14:30 UTC	2026-02	N020439-001	BETIMOL	0.25%	SOLUTION/DROPS / OPHTHALMIC		RLD	1995-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020439-002	BETIMOL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020439-001	BETIMOL	0.25%	SOLUTION/DROPS / OPHTHALMIC		RLD	1995-03-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020439-002	BETIMOL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020439-001	BETIMOL	0.25%	SOLUTION/DROPS / OPHTHALMIC		RLD	1995-03-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020439-002	BETIMOL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020439-001	BETIMOL	0.25%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1995-03-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020439-002	BETIMOL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020439-001	BETIMOL	0.25%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1995-03-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020439-002	BETIMOL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020439-001	BETIMOL	0.25%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1995-03-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020439-002	BETIMOL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020439-001	BETIMOL	0.25%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1995-03-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020439-002	BETIMOL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020439-001	BETIMOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1995-03-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020439-002	BETIMOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1995-03-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020439-001	BETIMOL	0.25%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1995-03-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020439-002	BETIMOL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020439-001	BETIMOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1995-03-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020439-002	BETIMOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1995-03-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020439-001	BETIMOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1995-03-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020439-002	BETIMOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1995-03-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020439-001	BETIMOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1995-03-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020439-002	BETIMOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1995-03-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020439-001	BETIMOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1995-03-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020439-002	BETIMOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1995-03-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020439-001	BETIMOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1995-03-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020439-002	BETIMOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1995-03-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020439-001	BETIMOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020439-002	BETIMOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020439-001	BETIMOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020439-002	BETIMOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020439-001	BETIMOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020439-002	BETIMOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020439-001	BETIMOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020439-002	BETIMOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020439-001	BETIMOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020439-002	BETIMOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020439-001	BETIMOL	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020439-002	BETIMOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1995-03-31	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 45 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020439-002	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020439-002	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020439-002	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020439-002	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020439-002	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020439-002	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020439-002	AT	1	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020439-002	AT	1	`d8e5a09893c0…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020439-001	AT	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020439-002	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020439-001	AT	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020439-002	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020439-001	AT	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020439-002	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020439-001	AT	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020439-002	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020439-001	AT	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020439-002	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020439-001	AT	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020439-002	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020439-001	AT	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020439-002	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020439-001	AT	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020439-002	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020439-001	AT	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020439-002	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020439-001	AT	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020439-002	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020439-001	AT	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020439-002	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020439-001	AT	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020439-002	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020439-001	AT	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020439-002	AT	1	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N020439-001	AT	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N020439-002	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020439-001	AT	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020439-002	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020439-001	AT	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N020439-002	AT	1	`f41ea6bd6efb…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TIMOLOL	2.56 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
817W3C6175	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
208560	Internal RxNorm lookup
1992305	Internal RxNorm lookup
2702393	Internal RxNorm lookup
2702398	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
3ae775f4-340c-4bf4-aa49-8a31daba0f8b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6c0c444-a6ba-2fb5-a7bc-7f0443fa5791	Product name	4	20251208
73103a56-9f57-4f32-a306-a42bfa2fea36	Product name	1	20250505
425025fc-f910-4afe-815b-58d4486ed4f7	Product name	4	20250331
26c5ddae-5c69-622d-e599-5fd583634968	Product name	4	20250313
ee780602-134c-4c60-a2f0-e973ba549cd4	Product name	2	20250304
03f77cb2-b4ad-3c11-8781-787b5ece4291	Product name	3	20240507
273981e4-09e7-45cc-967c-554f628ededf	Product name	3	20230627
97dad5a2-c524-a7b5-dede-82edefe9ce62	Product name	7	20220929
d11e749b-f93e-0ce3-ceda-28fe03d8081d	Product name	2	20190731

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82584-001-05	BETIMOL	1 in 1 CARTON	SOLUTION/ DROPS	1		6
82584-001-05	BETIMOL	5 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	5		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
82584-001-05	ML - Milliliter	82584-001	8764d6b1-5eba-436d-ae78-5a6b967ae6a0	1	2023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82584-001	BETIMOL (TIMOLOL) SOLUTION/ DROPS [THEA PHARMA INC.]	5	Current NDC, Legacy NDC, 2 package rows	20240430_3ae775f4-340c-4bf4-aa49-8a31daba0f8b.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BETIMOL	TIMOLOL	Thea Pharma Inc.	3ae775f4-340c-4bf4-aa49-8a31daba0f8b	2025-06-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020439 application number: NDA020439 ndc (product): 82584-001

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
817W3C6175	TIMOLOL	91524-16-2	TIMOLOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
208560	BETIMOL 0.25 % Ophthalmic Solution	PSN	3ae775f4-340c-4bf4-aa49-8a31daba0f8b	6
1992305	BETIMOL 0.5 % Ophthalmic Solution	PSN	3ae775f4-340c-4bf4-aa49-8a31daba0f8b	6
2702398	timolol hemihydrate 0.25 % Ophthalmic Solution	PSN	3ae775f4-340c-4bf4-aa49-8a31daba0f8b	6
2702393	timolol hemihydrate 0.5 % Ophthalmic Solution	PSN	3ae775f4-340c-4bf4-aa49-8a31daba0f8b	6
208560	timolol hemihydrate 2.5 MG/ML Ophthalmic Solution [Betimol]	SBD	3ae775f4-340c-4bf4-aa49-8a31daba0f8b	6
1992305	timolol hemihydrate 5 MG/ML Ophthalmic Solution [Betimol]	SBD	3ae775f4-340c-4bf4-aa49-8a31daba0f8b	6
2702398	timolol hemihydrate 2.5 MG/ML Ophthalmic Solution	SCD	3ae775f4-340c-4bf4-aa49-8a31daba0f8b	6
2702393	timolol hemihydrate 5 MG/ML Ophthalmic Solution	SCD	3ae775f4-340c-4bf4-aa49-8a31daba0f8b	6
208560	Betimol 0.25 % Ophthalmic Solution	SY	3ae775f4-340c-4bf4-aa49-8a31daba0f8b	6
1992305	Betimol 0.5 % Ophthalmic Solution	SY	3ae775f4-340c-4bf4-aa49-8a31daba0f8b	6
208560	Betimol 2.5 MG/ML (as timolol hemihydrate 2.56 MG/ML) Ophthalmic Solution	SY	3ae775f4-340c-4bf4-aa49-8a31daba0f8b	6
208560	Betimol 2.5 MG/ML Ophthalmic Solution	SY	3ae775f4-340c-4bf4-aa49-8a31daba0f8b	6
1992305	Betimol 5 MG/ML (as timolol hemihydrate 5.12 MG/ML) Ophthalmic Solution	SY	3ae775f4-340c-4bf4-aa49-8a31daba0f8b	6
2702398	timolol 2.5 MG/ML (as timolol hemihydrate 2.56 MG/ML) Ophthalmic Solution	SY	3ae775f4-340c-4bf4-aa49-8a31daba0f8b	6
2702393	timolol 5 MG/ML (as timolol hemihydrate 5.12 MG/ML) Ophthalmic Solution	SY	3ae775f4-340c-4bf4-aa49-8a31daba0f8b	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
82584-001-05	82584000105	1 BOTTLE, DROPPER in 1 CARTON (82584-001-05) > 5 mL in 1 BOTTLE, DROPPER	2022-12-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BETIMOL ® (timolol ophthalmic solution) 0.25%, 0.5%	Thea Pharma Inc.	2025-06-27	HUMAN PRESCRIPTION DRUG LABEL	6