FDA.reportPublic FDA data

Ammonium Lactate Lotion, 12%

Manufacturer
Zydus Lifesciences Limited
Effective date
2026-10-02
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-10-06 02:04:57

Label at a glance#

ProductAmmonium lactate
Active ingredientAMMONIUM LACTATE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1988-5

Ammonium lactate cream, 12%

140 grams

Rx

tube label
tube label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70771-198870771-1988-5, 70771-1988-6, 70771-1988-7

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
AMMONIUM LACTATE67M901L9NQACTIM
CETYL ALCOHOL936JST6JCNIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONO- AND DIPALMITOSTEARATEKC98RO82HJIACT
LAURETH-46HQ855798JIACT
LIGHT MINERAL OILN6K5787QVPIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
METHYLCELLULOSE, UNSPECIFIEDZ944H5SN0HIACT
METHYLPARABENA2I8C7HI9TIACT
PEG-100 MONOSTEARATEYD01N1999RIACT
POLYOXYL 40 STEARATE TYPE I13A4J4NH9IIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A217815-001AMMONIUM LACTATEAMMONIUM LACTATEEQ 12% BASECREAM / TOPICALAB2026-02-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217815-001AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A217815-001AMMONIUM LACTATEEQ 12% BASECREAM / TOPICALAB2026-02-12c2088c7a36db…
2026-09-14 22:38:342026-08A217815-001AMMONIUM LACTATEEQ 12% BASECREAM / TOPICALAB2026-02-1284e616aacf4f…
2026-08-18 06:07:402026-07A217815-001AMMONIUM LACTATEEQ 12% BASECREAM / TOPICALAB2026-02-12caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217815-001AMMONIUM LACTATEEQ 12% BASECREAM / TOPICALAB2026-02-12a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A217815-001AB1c2088c7a36db…
2026-09-14 22:38:342026-08A217815-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A217815-001AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217815-001AB1a50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ammonium lactateAMMONIUM LACTATEZydus Lifesciences Limited10a894e6-d23a-4142-8c9f-7bf96be9b9912026-10-02Exact identifier
ndc (package): 70771-1988-7
ndc (package): 70771-1988-6
ndc (package): 70771-1988-5
ndc (product): 70771-1988
ndc11 (package): 70771198806
ndc11 (package): 70771198805
ndc11 (package): 70771198807
spl id: 2fba2d8c-f152-49fd-88bf-2cec6a189264
spl set id: 10a894e6-d23a-4142-8c9f-7bf96be9b991

Reported adverse events (FAERS/openFDA)#

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