Ammonium Lactate

Product NDC
45802-419
11-digit product format
458020419
Labeler code
45802
Product ID
45802-419_6a24c09f-e06e-478f-9b67-4abe154e60ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ammonium Lactate
Dosage form
LOTION
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075570-001AMMONIUM LACTATEAMMONIUM LACTATEEQ 12% BASELOTION / TOPICALABRS2004-06-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075570-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A075570-001AMMONIUM LACTATEEQ 12% BASELOTION / TOPICALABRS2004-06-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075570-001AMMONIUM LACTATEEQ 12% BASELOTION / TOPICALABRS2004-06-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075570-001AMMONIUM LACTATEEQ 12% BASELOTION / TOPICALABRS2004-06-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A075570-001AMMONIUM LACTATEEQ 12% BASELOTION / TOPICALABRS2004-06-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075570-001AMMONIUM LACTATEEQ 12% BASELOTION / TOPICALABRS2004-06-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075570-001AMMONIUM LACTATEEQ 12% BASELOTION / TOPICALABRS2004-06-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075570-001AMMONIUM LACTATEEQ 12% BASELOTION / TOPICALABRS2004-06-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075570-001AMMONIUM LACTATEEQ 12% BASELOTION / TOPICALABRS2004-06-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075570-001AMMONIUM LACTATEEQ 12% BASELOTION / TOPICALABRS2004-06-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075570-001AMMONIUM LACTATEEQ 12% BASELOTION / TOPICALABRS2004-06-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075570-001AMMONIUM LACTATEEQ 12% BASELOTION / TOPICALABRS2004-06-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075570-001AMMONIUM LACTATEEQ 12% BASELOTION / TOPICALABRS2004-06-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075570-001AMMONIUM LACTATEEQ 12% BASELOTION / TOPICALABRS2004-06-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075570-001AMMONIUM LACTATEEQ 12% BASELOTION / TOPICALABRS2004-06-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075570-001AMMONIUM LACTATEEQ 12% BASELOTION / TOPICALABRS2004-06-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075570-001AMMONIUM LACTATEEQ 12% BASELOTION / TOPICALABRS2004-06-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075570-001AMMONIUM LACTATEEQ 12% BASELOTION / TOPICALABRS2004-06-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075570-001AMMONIUM LACTATEEQ 12% BASELOTION / TOPICALABRS2004-06-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075570-001AMMONIUM LACTATEEQ 12% BASELOTION / TOPICALABRS2004-06-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075570-001AMMONIUM LACTATEEQ 12% BASELOTION / TOPICALABRS2004-06-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075570-001AMMONIUM LACTATEEQ 12% BASELOTION / TOPICALABRS2004-06-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075570-001AMMONIUM LACTATEEQ 12% BASELOTION / TOPICALABRS2004-06-2387673890dc5c…
2021-03-12 10:30 UTC2021-03A075570-001AMMONIUM LACTATEEQ 12% BASELOTION / TOPICALABRS2004-06-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075570-001AMMONIUM LACTATEEQ 12% BASELOTION / TOPICALABRS2004-06-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075570-001AMMONIUM LACTATEEQ 12% BASELOTION / TOPICALABRS2004-06-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075570-001AMMONIUM LACTATEEQ 12% BASELOTION / TOPICALABRS2004-06-233f01610625f2…
2019-09-15 20:21 UTC2019-09A075570-001AMMONIUM LACTATEEQ 12% BASELOTION / TOPICALABRS2004-06-23b00525d2431f…
2019-07-19 19:46 UTC2019-07A075570-001AMMONIUM LACTATEEQ 12% BASELOTION / TOPICALABRS2004-06-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075570-001AMMONIUM LACTATEEQ 12% BASELOTION / TOPICALABRS2004-06-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075570-001AMMONIUM LACTATEEQ 12% BASELOTION / TOPICALABRS2004-06-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075570-001AMMONIUM LACTATEEQ 12% BASELOTION / TOPICALABRS2004-06-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075570-001AMMONIUM LACTATEEQ 12% BASELOTION / TOPICALABRS2004-06-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075570-001AMMONIUM LACTATEEQ 12% BASELOTION / TOPICALABRS2004-06-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075570-001AMMONIUM LACTATEEQ 12% BASELOTION / TOPICALABRS2004-06-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075570-001AMMONIUM LACTATEEQ 12% BASELOTION / TOPICALABRS2004-06-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A075570-001AMMONIUM LACTATEEQ 12% BASELOTION / TOPICALABRS2004-06-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A075570-001AMMONIUM LACTATEEQ 12% BASELOTION / TOPICALABRS2004-06-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075570-001AMMONIUM LACTATEEQ 12% BASELOTION / TOPICALABRS2004-06-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075570-001AMMONIUM LACTATEEQ 12% BASELOTION / TOPICALABRS2004-06-23f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075570-001AMMONIUM LACTATEEQ 12% BASELOTION / TOPICALABRS2004-06-23e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A075570-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075570-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075570-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075570-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075570-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075570-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075570-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075570-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075570-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075570-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075570-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075570-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075570-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075570-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075570-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075570-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075570-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075570-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075570-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075570-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075570-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075570-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A075570-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075570-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075570-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075570-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A075570-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075570-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075570-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075570-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075570-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075570-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075570-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075570-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075570-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A075570-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A075570-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075570-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075570-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075570-001AB1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Ammonium Lactate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMMONIUM LACTATE12 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
67M901L9NQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197362Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
dc3a6462-0f2c-4306-b5ef-c7b47395e959Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-419-26Ammonium Lactate400 g in 1 BOTTLE, PLASTICLOTION40010
45802-419-54Ammonium Lactate225 g in 1 BOTTLE, PLASTICLOTION22510

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-419-26GM - Gram45802-419fd26caa3-ac12-4425-a3da-4e45b51d6eea12012-07-24
45802-419-54GM - Gram45802-4199bccf240-95bc-47ea-9002-d9ccb983e02512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMMONIUM LACTATEACTIVE INGREDIENT67M901L9NQAMMONIUM LACTATE LOTION [PERRIGO NEW YORK INC]4
LACTIC ACID, DL-ACTIVE MOIETY3B8D35Y7S4AMMONIUM LACTATE LOTION [PERRIGO NEW YORK INC]4
AMMONIUM LACTATEACTIVE INGREDIENT67M901L9NQAMMONIUM LACTATE LOTION [PHYSICIANS TOTAL CARE, INC.]1
LACTIC ACID, DL-ACTIVE MOIETY3B8D35Y7S4AMMONIUM LACTATE LOTION [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-419AMMONIUM LACTATE LOTION [PADAGIS ISRAEL PHARMACEUTICALS LTD]9Current NDC, Legacy NDC, 2 package rows20220927_dc3a6462-0f2c-4306-b5ef-c7b47395e959.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ammonium LactateAMMONIUM LACTATEPadagis Israel Pharmaceuticals Ltddc3a6462-0f2c-4306-b5ef-c7b47395e9592025-06-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075570
application number: ANDA075570
ndc (product): 45802-419
Ammonium LactateAMMONIUM LACTATEBryant Ranch Prepack99a5db95-7b48-46f1-99c7-db1c9ea656812024-02-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075570
application number: ANDA075570
Ammonium LactateAMMONIUM LACTATEBryant Ranch Prepack1d2adae5-0225-4e66-8f4f-14a5ef11e1d02023-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075570
application number: ANDA075570
Ammonium LactateAMMONIUM LACTATEBryant Ranch Prepack7a23d405-a48c-482f-9b28-6ae851ccefe32023-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075570
application number: ANDA075570

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197362ammonium lactate 12 % Topical LotionPSN1d2adae5-0225-4e66-8f4f-14a5ef11e1d0105
197362ammonium lactate 120 MG/ML Topical LotionSCD1d2adae5-0225-4e66-8f4f-14a5ef11e1d0105
197362ammonium lactate 12 % Topical LotionSY1d2adae5-0225-4e66-8f4f-14a5ef11e1d0105
197362ammonium lactate 120 MG/ML (as neutralized lactic acid 12 % ) Topical LotionSY1d2adae5-0225-4e66-8f4f-14a5ef11e1d0105
197362ammonium lactate 12 % Topical LotionPSN7a23d405-a48c-482f-9b28-6ae851ccefe3104
197362ammonium lactate 120 MG/ML Topical LotionSCD7a23d405-a48c-482f-9b28-6ae851ccefe3104
197362ammonium lactate 12 % Topical LotionSY7a23d405-a48c-482f-9b28-6ae851ccefe3104
197362ammonium lactate 120 MG/ML (as neutralized lactic acid 12 % ) Topical LotionSY7a23d405-a48c-482f-9b28-6ae851ccefe3104
197362ammonium lactate 12 % Topical LotionPSN99a5db95-7b48-46f1-99c7-db1c9ea65681100
197362ammonium lactate 120 MG/ML Topical LotionSCD99a5db95-7b48-46f1-99c7-db1c9ea65681100
197362ammonium lactate 12 % Topical LotionSY99a5db95-7b48-46f1-99c7-db1c9ea65681100
197362ammonium lactate 120 MG/ML (as neutralized lactic acid 12 % ) Topical LotionSY99a5db95-7b48-46f1-99c7-db1c9ea65681100
197362ammonium lactate 12 % Topical LotionPSNdc3a6462-0f2c-4306-b5ef-c7b47395e95910
197362ammonium lactate 120 MG/ML Topical LotionSCDdc3a6462-0f2c-4306-b5ef-c7b47395e95910
197362ammonium lactate 12 % Topical LotionSYdc3a6462-0f2c-4306-b5ef-c7b47395e95910
197362ammonium lactate 120 MG/ML (as neutralized lactic acid 12 % ) Topical LotionSYdc3a6462-0f2c-4306-b5ef-c7b47395e95910
197362ammonium lactate 12 % Topical LotionPSNdc577a65-3330-4f29-9b4e-a18952ea11eb1
197362ammonium lactate 120 MG/ML Topical LotionSCDdc577a65-3330-4f29-9b4e-a18952ea11eb1
197362ammonium lactate 12 % Topical LotionSYdc577a65-3330-4f29-9b4e-a18952ea11eb1
197362ammonium lactate 120 MG/ML (as neutralized lactic acid 12 % ) Topical LotionSYdc577a65-3330-4f29-9b4e-a18952ea11eb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-419-2645802041926400 g in 1 BOTTLE, PLASTIC (45802-419-26) 400 g2006-06-200000-00-00NoNoCurrent
45802-419-5445802041954225 g in 1 BOTTLE, PLASTIC (45802-419-54) 225 g2006-06-200000-00-00NoNoCurrent