Ammonium Lactate

Product NDC: 63629-8609
11-digit product format: 636298609
Labeler code: 63629
Product ID: 63629-8609_00b2bf41-a961-6394-e063-6394a90ac8fc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ammonium Lactate
Dosage form: CREAM
Route: TOPICAL
Labeler: Bryant Ranch Prepack
Application: ANDA075774
Marketing category: ANDA
Marketing start: 2006-08-16
Substance: AMMONIUM LACTATE
Active strength: 12 g/100g
Pharmacologic classes: Acidifying Activity [MoA]
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
A075774-001	AMMONIUM LACTATE	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB		2002-05-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075774-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A075774-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB		2002-05-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075774-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB		2002-05-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075774-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB	RS	2002-05-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075774-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB	RS	2002-05-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075774-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB	RS	2002-05-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075774-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB	RS	2002-05-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075774-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB	RS	2002-05-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075774-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB	RS	2002-05-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075774-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB	RS	2002-05-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075774-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB	RS	2002-05-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075774-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB	RS	2002-05-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075774-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB	RS	2002-05-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075774-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB	RS	2002-05-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075774-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB	RS	2002-05-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075774-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB	RS	2002-05-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075774-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB	RS	2002-05-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075774-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB	RS	2002-05-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075774-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB	RS	2002-05-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075774-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB	RS	2002-05-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075774-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB	RS	2002-05-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075774-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB	RS	2002-05-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075774-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB	RS	2002-05-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075774-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB	RS	2002-05-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075774-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB	RS	2002-05-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075774-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB	RS	2002-05-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075774-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB	RS	2002-05-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075774-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB	RS	2002-05-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075774-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB	RS	2002-05-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075774-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB	RS	2002-05-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075774-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB	RS	2002-05-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075774-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB	RS	2002-05-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075774-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB	RS	2002-05-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075774-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB	RS	2002-05-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075774-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB	RS	2002-05-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075774-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB	RS	2002-05-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075774-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB	RS	2002-05-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075774-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB	RS	2002-05-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075774-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB	RS	2002-05-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075774-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB	RS	2002-05-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075774-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB	RS	2002-05-01	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A075774-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075774-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075774-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075774-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075774-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075774-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075774-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075774-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075774-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075774-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075774-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075774-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075774-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075774-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075774-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075774-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075774-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075774-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075774-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075774-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075774-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075774-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075774-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075774-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075774-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075774-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075774-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075774-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075774-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075774-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075774-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075774-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075774-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075774-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075774-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075774-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075774-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075774-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075774-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075774-001	AB	1	`e64feba35796…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMMONIUM LACTATE	12 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
67M901L9NQ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
543460	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
2455f1aa-562d-424a-9542-4853adf1ca75	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63629-8609-1	Ammonium Lactate	385 g in 1 BOTTLE, PUMP	CREAM	385		103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-8609-1	GM - Gram	63629-8609	1a742135-bf76-4055-8dce-3d74b4cbdf6d	1	2023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-8609	AMMONIUM LACTATE CREAM [BRYANT RANCH PREPACK]	103	Current NDC, Legacy NDC, 1 package rows	20230718_2455f1aa-562d-424a-9542-4853adf1ca75.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ammonium Lactate	AMMONIUM LACTATE	Padagis Israel Pharmaceuticals Ltd	7096d38e-2bd1-4374-9bf6-7fd09ef7509c	2025-11-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075774 application number: ANDA075774
Ammonium Lactate	AMMONIUM LACTATE	Bryant Ranch Prepack	170f8764-a180-49fa-b406-44f5b7921a66	2024-04-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075774 application number: ANDA075774
Ammonium Lactate	AMMONIUM LACTATE	Bryant Ranch Prepack	411b40c7-4d62-4ea4-be69-bea5d1d591ca	2023-08-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075774 application number: ANDA075774
Ammonium Lactate	AMMONIUM LACTATE	Bryant Ranch Prepack	2455f1aa-562d-424a-9542-4853adf1ca75	2023-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075774 application number: ANDA075774 ndc (product): 63629-8609

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
67M901L9NQ	AMMONIUM LACTATE	515-98-0	AMMONIUM LACTATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
543460	ammonium lactate 12 % Topical Cream	PSN	2455f1aa-562d-424a-9542-4853adf1ca75	103
543460	ammonium lactate 120 MG/ML Topical Cream	SCD	2455f1aa-562d-424a-9542-4853adf1ca75	103
543460	ammonium lactate 12 % Topical Cream	SY	2455f1aa-562d-424a-9542-4853adf1ca75	103
543460	ammonium lactate 120 MG/ML (as neutralized lactic acid 12 % ) Topical Cream	SY	2455f1aa-562d-424a-9542-4853adf1ca75	103

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-8609-1	63629860901	385 g in 1 BOTTLE, PUMP (63629-8609-1)	385 g	2007-02-19	0000-00-00	No	No	Current