Ammonium Lactate

Product NDC: 72162-1407
11-digit product format: 721621407
Labeler code: 72162
Product ID: 72162-1407_413e3e1f-f22c-49b0-bcea-76799fd0e3a8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ammonium Lactate
Dosage form: LOTION
Route: TOPICAL
Labeler: Bryant Ranch Prepack
Application: ANDA075570
Marketing category: ANDA
Marketing start: 2006-06-20
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
A075570-001	AMMONIUM LACTATE	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	RS	2004-06-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075570-001	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	A075570-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	RS	2004-06-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075570-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	RS	2004-06-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075570-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	RS	2004-06-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075570-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	RS	2004-06-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075570-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	RS	2004-06-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075570-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	RS	2004-06-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075570-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	RS	2004-06-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075570-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	RS	2004-06-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075570-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	RS	2004-06-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075570-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	RS	2004-06-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075570-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	RS	2004-06-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075570-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	RS	2004-06-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075570-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	RS	2004-06-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075570-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	RS	2004-06-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075570-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	RS	2004-06-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075570-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	RS	2004-06-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075570-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	RS	2004-06-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075570-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	RS	2004-06-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075570-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	RS	2004-06-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075570-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	RS	2004-06-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075570-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	RS	2004-06-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075570-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	RS	2004-06-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075570-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	RS	2004-06-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075570-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	RS	2004-06-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075570-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	RS	2004-06-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075570-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	RS	2004-06-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075570-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	RS	2004-06-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075570-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	RS	2004-06-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075570-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	RS	2004-06-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075570-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	RS	2004-06-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075570-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	RS	2004-06-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075570-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	RS	2004-06-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075570-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	RS	2004-06-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075570-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	RS	2004-06-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075570-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	RS	2004-06-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075570-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	RS	2004-06-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075570-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	RS	2004-06-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075570-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	RS	2004-06-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075570-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	RS	2004-06-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075570-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	RS	2004-06-23	`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	A075570-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075570-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075570-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075570-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075570-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075570-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075570-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075570-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075570-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075570-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075570-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075570-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075570-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075570-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075570-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075570-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075570-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075570-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075570-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075570-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075570-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075570-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075570-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075570-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075570-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075570-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075570-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075570-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075570-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075570-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075570-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075570-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075570-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075570-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075570-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075570-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075570-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075570-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075570-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075570-001	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
197362	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
99a5db95-7b48-46f1-99c7-db1c9ea65681	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
72162-1407-2	Ammonium Lactate	225 g in 1 BOTTLE, PLASTIC	LOTION	225		100
72162-1407-4	Ammonium Lactate	400 g in 1 BOTTLE, PLASTIC	LOTION	400		100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72162-1407-2	GM - Gram	72162-1407	708090b8-898f-433b-97ab-21ad1813b0fa	1	2024-05-16
72162-1407-4	GM - Gram	72162-1407	38da5cfe-f31d-4db6-8533-72459c231d34	1	2024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72162-1407	AMMONIUM LACTATE LOTION [BRYANT RANCH PREPACK]	100	Current NDC, 2 package rows	20240209_99a5db95-7b48-46f1-99c7-db1c9ea65681.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	dc3a6462-0f2c-4306-b5ef-c7b47395e959	2025-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075570 application number: ANDA075570
Ammonium Lactate	AMMONIUM LACTATE	Bryant Ranch Prepack	99a5db95-7b48-46f1-99c7-db1c9ea65681	2024-02-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075570 application number: ANDA075570 ndc (product): 72162-1407
Ammonium Lactate	AMMONIUM LACTATE	Bryant Ranch Prepack	1d2adae5-0225-4e66-8f4f-14a5ef11e1d0	2023-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075570 application number: ANDA075570
Ammonium Lactate	AMMONIUM LACTATE	Bryant Ranch Prepack	7a23d405-a48c-482f-9b28-6ae851ccefe3	2023-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075570 application number: ANDA075570

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
197362	ammonium lactate 12 % Topical Lotion	PSN	99a5db95-7b48-46f1-99c7-db1c9ea65681	100
197362	ammonium lactate 120 MG/ML Topical Lotion	SCD	99a5db95-7b48-46f1-99c7-db1c9ea65681	100
197362	ammonium lactate 12 % Topical Lotion	SY	99a5db95-7b48-46f1-99c7-db1c9ea65681	100
197362	ammonium lactate 120 MG/ML (as neutralized lactic acid 12 % ) Topical Lotion	SY	99a5db95-7b48-46f1-99c7-db1c9ea65681	100

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72162-1407-2	72162140702	225 g in 1 BOTTLE, PLASTIC (72162-1407-2)	225 g	2024-02-08	No	No	Current
72162-1407-4	72162140704	400 g in 1 BOTTLE, PLASTIC (72162-1407-4)	400 g	2024-02-08	No	No	Current