FDA.reportPublic FDA data

ammonium lactate 120 MG/ML Topical Lotion

RxCUI
197362
RxNorm name
ammonium lactate 120 MG/ML Topical Lotion
Display name
Lactate (Topical)
Full name
ammonium lactate 120 MG/ML Topical Lotion
Term type
SCD
Status
Active
Strength
12%
Dose form
Lotion
Route
Topical
Updated
2026-11-02 18:17:44

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
042005
Active start
042005
Multiple ingredient
NO
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
ammonium lactate120 MG / 1 MLlactatelactic acid

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Topical Lotion316983

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
lactate114202

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRammonium lactate 120 MG/ML Topical Lotion1NAMES
RxNorm Nameammonium lactate 120 MG/ML Topical Lotion1NAMES
RxNorm Synonym
2 linked values
2NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID
6 linked values
6CODES
RxCUI1973621CODES
MMSL_CODE
3 linked values
3CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
45802-419-2645802-419Ammonium Lactate Ammonium LactatePadagis Israel Pharmaceuticals LtdANDA075570
45802-419-5445802-419Ammonium Lactate Ammonium LactatePadagis Israel Pharmaceuticals LtdANDA075570
50090-6587-050090-6587Ammonium Lactate Ammonium LactateA-S Medication SolutionsANDA076216
51672-1300-551672-1300Ammonium Lactate Ammonium LactateSun Pharmaceutical Industries, Inc.ANDA076216
51672-1300-951672-1300Ammonium Lactate Ammonium LactateSun Pharmaceutical Industries, Inc.ANDA076216
63629-8610-163629-8610Ammonium Lactate Ammonium LactateBryant Ranch PrepackANDA075570
63629-8611-163629-8611Ammonium Lactate Ammonium LactateBryant Ranch PrepackANDA075570
72162-1407-272162-1407Ammonium Lactate Ammonium LactateBryant Ranch PrepackANDA075570
72162-1407-472162-1407Ammonium Lactate Ammonium LactateBryant Ranch PrepackANDA075570

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA07557045802-419Ammonium Lactate Ammonium LactateANDAPadagis Israel Pharmaceuticals Ltd
ANDA07621650090-6587Ammonium Lactate Ammonium LactateANDAA-S Medication Solutions

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 53 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00904598426rxnav_ndcsyes
00904598463rxnav_ndcsyes
10939096105rxnav_ndcsyes
10939096106rxnav_ndcsyes
45802041926rxnav_ndcsyes
45802041954rxnav_ndcsyes
45802052526rxnav_ndcsyes
45802052555rxnav_ndcsyes
50090658700rxnav_ndcsyes
51672130005rxnav_ndcsyes
51672130009rxnav_ndcsyes
63044048409rxnav_ndcsyes
63629861001rxnav_ndcsyes
63629861101rxnav_ndcsyes
71399001408rxnav_ndcsyes
71399014004rxnav_ndcsyes
71399014008rxnav_ndcsyes
72162140702rxnav_ndcsyes
72162140704rxnav_ndcsyes
00072571205rxnav_historical
00072571208rxnav_historical
00072571214rxnav_historical
00245002216rxnav_historical
00245002304rxnav_historical
00245002322rxnav_historical
00245002340rxnav_historical
00247095301rxnav_historical
00247095401rxnav_historical
00574202108rxnav_historical
00574202116rxnav_historical
00591215822rxnav_historical
00591215846rxnav_historical
09277161208rxnav_historical
09277161214rxnav_historical
13279031008rxnav_historical
13279031014rxnav_historical
50428047796rxnav_historical
50428705146rxnav_historical
50428803406rxnav_historical
53002099199rxnav_historical
54569388300rxnav_historical
54868226200rxnav_historical
54868226203rxnav_historical
54868459900rxnav_historical
54868459901rxnav_historical
55887047308rxnav_historical
59366410002rxnav_historical
59366410004rxnav_historical
59772581001rxnav_historical
61360130005rxnav_historical
61360130009rxnav_historical
63218023508rxnav_historical
63218023514rxnav_historical

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ammonium LactateAMMONIUM LACTATESun Pharmaceutical Industries, Inc.8bb09bb3-5bbc-489d-96c1-ae97cb58381e2026-07-30Warnings, Adverse reactionsExact identifier
ndc (package): 51672-1300-5
ndc (package): 51672-1300-9
ndc (product): 51672-1300
ndc11 (package): 51672130009
ndc11 (package): 51672130005
rxcui: 197362
Ammonium LactateAMMONIUM LACTATEPadagis Israel Pharmaceuticals Ltddc3a6462-0f2c-4306-b5ef-c7b47395e9592025-06-30Warnings, Adverse reactionsExact identifier
ndc (package): 45802-419-26
ndc (package): 45802-419-54
ndc (product): 45802-419
ndc11 (package): 45802041926
ndc11 (package): 45802041954
rxcui: 197362
Ammonium LactateAMMONIUM LACTATEBryant Ranch Prepack99a5db95-7b48-46f1-99c7-db1c9ea656812024-02-08Warnings, Adverse reactionsExact identifier
ndc (package): 72162-1407-4
ndc (package): 72162-1407-2
ndc (product): 72162-1407
ndc11 (package): 72162140704
ndc11 (package): 72162140702
rxcui: 197362
Ammonium LactateAMMONIUM LACTATEA-S Medication Solutionsab54704d-ace2-410c-b0af-2fa13462a8b32023-08-24Warnings, Adverse reactionsExact identifier
ndc (package): 50090-6587-0
ndc (product): 50090-6587
ndc11 (package): 50090658700
rxcui: 197362
Ammonium LactateAMMONIUM LACTATEBryant Ranch Prepack1d2adae5-0225-4e66-8f4f-14a5ef11e1d02023-07-17Warnings, Adverse reactionsExact identifier
ndc (package): 63629-8610-1
ndc (product): 63629-8610
ndc11 (package): 63629861001
rxcui: 197362
Ammonium LactateAMMONIUM LACTATEBryant Ranch Prepack7a23d405-a48c-482f-9b28-6ae851ccefe32023-07-17Warnings, Adverse reactionsExact identifier
ndc (package): 63629-8611-1
ndc (product): 63629-8611
ndc11 (package): 63629861101
rxcui: 197362

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 10 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
1d2adae5-0225-4e66-8f4f-14a5ef11e1d0ammonium lactate 12 % Topical Lotion [PSN] · ammonium lactate 120 MG/ML Topical Lotion [SCD] · ammonium lactate 12 % Topical Lotion [SY] · ammonium lactate 120 MG/ML (as neutralized lactic acid 12 % ) Topical Lotion [SY]4105Ammonium Lactate Lotion, 12%*20230717
7a23d405-a48c-482f-9b28-6ae851ccefe3ammonium lactate 12 % Topical Lotion [PSN] · ammonium lactate 120 MG/ML Topical Lotion [SCD] · ammonium lactate 12 % Topical Lotion [SY] · ammonium lactate 120 MG/ML (as neutralized lactic acid 12 % ) Topical Lotion [SY]4104Ammonium Lactate Lotion, 12%*20230717
99a5db95-7b48-46f1-99c7-db1c9ea65681ammonium lactate 12 % Topical Lotion [PSN] · ammonium lactate 120 MG/ML Topical Lotion [SCD] · ammonium lactate 12 % Topical Lotion [SY] · ammonium lactate 120 MG/ML (as neutralized lactic acid 12 % ) Topical Lotion [SY]4100Ammonium Lactate Lotion, 12%*20240208
dc3a6462-0f2c-4306-b5ef-c7b47395e959ammonium lactate 12 % Topical Lotion [PSN] · ammonium lactate 120 MG/ML Topical Lotion [SCD] · ammonium lactate 12 % Topical Lotion [SY] · ammonium lactate 120 MG/ML (as neutralized lactic acid 12 % ) Topical Lotion [SY]410Ammonium Lactate Lotion, 12%*20250630
8bb09bb3-5bbc-489d-96c1-ae97cb58381eammonium lactate 12 % Topical Lotion [PSN] · ammonium lactate 120 MG/ML Topical Lotion [SCD] · ammonium lactate 12 % Topical Lotion [SY] · ammonium lactate 120 MG/ML (as neutralized lactic acid 12 % ) Topical Lotion [SY]46Ammonium Lactate Lotion 12%*20250701
ab54704d-ace2-410c-b0af-2fa13462a8b3ammonium lactate 12 % Topical Lotion [PSN] · ammonium lactate 120 MG/ML Topical Lotion [SCD] · ammonium lactate 12 % Topical Lotion [SY] · ammonium lactate 120 MG/ML (as neutralized lactic acid 12 % ) Topical Lotion [SY]43Ammonium Lactate Lotion 12%*20230824
5d2efce6-3cb4-4c86-b899-c1611a25384eammonium lactate 12 % Topical Lotion [PSN] · ammonium lactate 120 MG/ML Topical Lotion [SCD] · ammonium lactate 12 % Topical Lotion [SY] · ammonium lactate 120 MG/ML (as neutralized lactic acid 12 % ) Topical Lotion [SY]41Geri-Hydrolac 12% Lotion20130510
dc577a65-3330-4f29-9b4e-a18952ea11ebammonium lactate 12 % Topical Lotion [PSN] · ammonium lactate 120 MG/ML Topical Lotion [SCD] · ammonium lactate 12 % Topical Lotion [SY] · ammonium lactate 120 MG/ML (as neutralized lactic acid 12 % ) Topical Lotion [SY]41AMMONIUM LACTATE LOTION, 12%*20120418
c81529fe-95b6-4b11-bfc8-cc5f9b8952d3ammonium lactate 12 % Topical Lotion [PSN] · ammonium lactate 120 MG/ML Topical Lotion [SCD] · ammonium lactate 12 % Topical Lotion [SY] · ammonium lactate 120 MG/ML (as neutralized lactic acid 12 % ) Topical Lotion [SY]41Ammonium Lactate Lotion20091229
3d94a218-ae4d-4158-bd8e-92743c7c8e0dammonium lactate 12 % Topical Lotion [PSN] · ammonium lactate 120 MG/ML Topical Lotion [SCD] · ammonium lactate 12 % Topical Lotion [SY] · ammonium lactate 120 MG/ML (as neutralized lactic acid 12 % ) Topical Lotion [SY]41Lac-Hydrin ® (ammonium lactate) Lotion 12%20080128

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
8bb09bb3-5bbc-489d-96c1-ae97cb58381eAmmonium Lactate Lotion 12%*Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.20260730
8bb09bb3-5bbc-489d-96c1-ae97cb58381eAmmonium Lactate Lotion 12%*Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.20250701
dc3a6462-0f2c-4306-b5ef-c7b47395e959Ammonium Lactate Lotion, 12%*Padagis Israel Pharmaceuticals Ltd20250630
dc3a6462-0f2c-4306-b5ef-c7b47395e959Ammonium Lactate Lotion, 12%*Padagis Israel Pharmaceuticals Ltd20250630
99a5db95-7b48-46f1-99c7-db1c9ea65681Ammonium Lactate Lotion, 12%*Bryant Ranch Prepack20240208
ab54704d-ace2-410c-b0af-2fa13462a8b3Ammonium Lactate Lotion 12%*A-S Medication Solutions20230824
1d2adae5-0225-4e66-8f4f-14a5ef11e1d0Ammonium Lactate Lotion, 12%*Bryant Ranch Prepack20230717
7a23d405-a48c-482f-9b28-6ae851ccefe3Ammonium Lactate Lotion, 12%*Bryant Ranch Prepack20230717
dc3a6462-0f2c-4306-b5ef-c7b47395e959Ammonium Lactate Lotion, 12%*Padagis Israel Pharmaceuticals Ltd20220723
93bbaa09-9817-4855-aaa9-3d955d2bce39Ammonium Lactate Lotion, 12%*V2 Pharma, LLC | Taro Pharmaceuticals Inc. | G&W Laboratories, Inc.20190613
55c75d67-c0f1-42ad-b9ac-29543c5cfb88National Council for Prescription Drug Programs20130213
d6b7e3da-2520-4366-b1e2-75600fdfbd90National Council for Prescription Drug Programs20130213
fd26caa3-ac12-4425-a3da-4e45b51d6eeaNational Council for Prescription Drug Programs20120724
0748bb8f-40ee-4111-9d82-6d9fc9ce92c0National Council for Prescription Drug Programs20120724
f3e5b834-7369-4e84-9ce1-821a26e0aa25National Council for Prescription Drug Programs20120724
e7b6d29c-e373-44ab-a3cb-3ad3b3cee0d7National Council for Prescription Drug Programs20120724
9bccf240-95bc-47ea-9002-d9ccb983e025National Council for Prescription Drug Programs20120724
7ae48f7e-9a3e-4e94-bdd3-993f3280709bNational Council for Prescription Drug Programs20120724
6fc0f35c-940f-49d3-a204-1bf49eee0356National Council for Prescription Drug Programs20120724
560a6a3d-987c-449e-b067-ff59ed077a39National Council for Prescription Drug Programs20120724
48a1307c-3cda-41e8-99ab-320e471f88b5National Council for Prescription Drug Programs20120724
13c5ec7d-274c-4976-b63d-ada0dc6aaab3National Council for Prescription Drug Programs20120724
dc577a65-3330-4f29-9b4e-a18952ea11ebAMMONIUM LACTATE LOTION, 12%*Physicians Total Care, Inc.20120418
c81529fe-95b6-4b11-bfc8-cc5f9b8952d3Ammonium Lactate LotionNnodum Pharmaceuticals | Alliance Packaging Group20091229
3d94a218-ae4d-4158-bd8e-92743c7c8e0dLac-Hydrin ® (ammonium lactate) Lotion 12%Ranbaxy, Inc20080128

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
FDASPLD006880Hydroxy AcidsCHEMhas_chemical_structureammonium lactate
FDASPLN0000175842alpha-Hydroxy AcidEPChas_epcammonium lactate
MEDRTD019344Lactic AcidCHEMhas_ingredientlactate
MEDRTD019344Lactic AcidCHEMhas_ingredientammonium lactate
MEDRTD004342Drug HypersensitivityDISEASEci_withammonium lactate
MEDRTD016112Ichthyosis VulgarisDISEASEmay_treatammonium lactate
MEDRTN0000009915Unknown Cellular or Molecular InteractionMOAhas_moaammonium lactate
MEDRTN0000009735Decreased Skin KeratinizationPEhas_peammonium lactate
MEDRTN0000009035Emollient ActivityPEhas_peammonium lactate

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH120 MG/ML (expressed as ammonium lactate)
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESANDAANDA075570
CODESANDAANDA076216
CODESVUID4005831
NAMESPrescribable Synonymammonium lactate 12 % Topical Lotion
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceNational Drug Data File Plus Source Vocabulary
SOURCESSourceVeterans Health Administration National Drug File