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Ammonium Lactate 12 g/100g Cream, 385 g — NDC 45802-0493-38 package photo

Ammonium Lactate 12 g/100g Cream, 385 g

by Padagis Israel Pharmaceuticals Ltd · 385 g in 1 BOTTLE (45802-493-38)
NDC 45802-0493-38
🏷️ FDA NDC (as labeled) 45802-493-38 billing pads the product segment with a zero
This package
Contains385 g Cost per g$0.0668 NADAC Per package$25.72 / 385 g Pack sizes4 compare ↓
Also priced by: Part D plans $0.0883/unit — full pricing hub ↓
Also comes in: 2 tubes 45802-0493-83 140 g 45802-0493-98 385 g 45802-0493-26
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 45802-493-38
Product NDC 45802-493
11-digit billing NDC 45802049338
NCPDP billing unit GM — per gram (weight)
RxCUI 543460
UNII 67M901L9NQ
Application # ANDA075774
SPL Set ID 7096d38e-2bd1-4374-9bf6-7fd09ef7509c
Established class (EPC) alpha-Hydroxy Acid
Chemical class Hydroxy Acids
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2006-08-16
Route TOPICAL
Dosage form CREAM
Substance AMMONIUM LACTATE
GPI-14 90650015003730
GPI class Ammonium Lactate
GCN Seq No 028191
GCN 23043
HICL code 015560
Ingredient (HICL) Ammonium Lactate
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L2
Therapeutic class — intermediate (HIC2) Emollients
HIC3 code L2A
Therapeutic class — specific (HIC3) Emollients
AHFS code 84:24.12.00
AHFS class Basic Ointments And Protectants
FDB label name AMMONIUM LACTATE 12% CREAM
FDB brand name Ammonium Lactate
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 45802-493-38 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 45802-0493-38. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Organic acids class.

Drug family (ATC) Organic acids
How it works Acidifying Activity
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerPadagis Israel Pharmaceuticals Ltd
Application holderPADAGIS ISRAEL PHARMACEUTICALS LTD
FDA applicationANDA075774 (ANDA)
Labeler code45802
First marketedAug 2006
Product typeHuman Prescription Drug
Portfolio175 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name AMMONIUM LACTATE 12% CREAM Ingredient Ammonium Lactate
📖 What it is MedlinePlus · NLM

Ammonium lactate is used to treat xerosis (dry or scaly skin) and ichthyosis vulgaris (an inherited dry skin condition) in adults and children. Ammonium lactate is in a class of medications called alpha-hydroxy acids. It works by increasing skin hydration.

Read the full MedlinePlus article ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • UNII 6HQ855798J
    Laureth-4 is a synthetic detergent made from lauryl alcohol and ethylene oxide. It acts as an emulsifier and solubilizer, helping blend oil and water-based ingredients and improve how the body absorbs the active drug.
  • UNII N6K5787QVP
    Light mineral oil is a clear, odorless liquid derived from petroleum. In medicines, it acts as a lubricant and emollient to help the product spread smoothly and improve texture.
  • UNII 6M3P64V0NC
    A fine powder made from magnesium, aluminum, and silicon compounds. It absorbs moisture and helps keep medicine ingredients from clumping or separating, so the product stays stable and flows smoothly during manufacturing.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII YD01N1999R
    A waxy substance made from polyethylene glycol and stearic acid. It helps mix oil and water-based ingredients together and serves as an emulsifier and solubilizer in liquid and semi-solid medicines.
  • UNII 13A4J4NH9I
    A synthetic emulsifier derived from stearic acid and polyethylene glycol. It helps mix oil and water-based ingredients together in liquid medicines and creams to create a smooth, uniform product.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

12 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly $0.067 $25.72 / 385 g
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.0883 $34.00 / 385 g
NADAC price history (per g) — tap or hover for the price & month
Apr 2026 May 2026 Jul 2026 Sep 2026 $0.070 $0.067
▼ Down 5% over the last 6 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ammonium Lactate 12 g/100gthis 45802-0493-38 Padagis 385 g $0.067 AB Availability likely —
Ammonium Lactate 120 mg/g 51672-1301-00 Sun 385 g $0.067 AB Availability likely —
Ammonium Lactate 12 g/100g 45802-0419-26 Padagis 400 g $0.072 AB Availability likely +8%
Ammonium Lactate 12 g/100g 63629-8608-01 Bryant 2 tubes — AB FDA listed —
Ammonium Lactate 12 g/100g 63629-8609-01 Bryant 385 g — AB FDA listed —
Ammonium Lactate 120 mg/g 70518-3619-00 REMEDYREPACK 2 tubes — AB FDA listed —
Ammonium Lactate 12 g/100g 72162-1413-02 Bryant 2 tubes — AB FDA listed —
Ammonium Lactate 12 g/100g 63629-8610-01 Bryant 225 g — AB FDA listed —
Ammonium Lactate 12 g/100g 63629-8611-01 Bryant 400 g — AB FDA listed —
Ammonium Lactate 12 g/100g 72162-1407-02 Bryant 225 g — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2006
On the market since
Aug 2006
📍
2026
Currently FDA-listed
20 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
385 gs45802-0493-26 18,574 Rx · $517,542
2 tubes45802-0493-83 1,315 Rx · $20,009
140 gs45802-0493-98 No Medicaid data
385 gs this page45802-0493-38 No Medicaid data
Drug total (last 4 qtrs): 19,889 Rx · 7,251,390 units · $537,552 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Ammonium Lactate — the program that covers self-administered drugs. 3 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Ammonium Lactate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$7.57M
Claims incl. refills
359.4K
Beneficiaries
250K
Spend / beneficiary
$30.29
Spend / claim
$21.07
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Ammonium Lactate — the ingredient across all brands.

Top reported reactions

Fatigue149
Pain148
Diarrhoea140
Chronic Kidney Disease127
Nausea126
Dyspnoea115
Rash110

Reporter sex

0 reports
Male · 41%
Female · 59%
Unknown · 0%

Serious outcomes

Disabling44
Life-threatening31
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 238 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
45802-0493-26 385 g in 1 BOTTLE, PUMP (45802-493-26) $0.0668 / g $25.72 2007-02-19 Active
45802-0493-83 2 TUBE in 1 CARTON (45802-493-83) / 140 g in 1 TUBE $0.0573 / g $16.04 2007-01-25 Active
45802-0493-98 140 g in 1 TUBE (45802-493-98) — — 2006-08-16 Active
45802-0493-38 You're viewing this 385 g in 1 BOTTLE (45802-493-38) $0.0668 / g $25.72 2026-03-16 Active

Per g, this pack runs about 17% above the cheapest pack (NDC 45802-0493-83, $0.0573 vs $0.0668 NADAC).

This pack shows little to no recent Medicaid volume — the 385 gs pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 45802-0493-38?
NDC 45802-0493-38 contains 385 g — 385 g in 1 bottle.
What is the difference between NDC 45802-0493-38 and NDC 45802-0493-98?
Both are Ammonium Lactate 12 g/100g Cream — the drug itself is identical. NDC 45802-0493-38 is the 385 g package, while NDC 45802-0493-98 is the 140 g package.
What NDC number is used to bill for this package of Ammonium Lactate 12 g/100g Cream?
Bill NDC 45802-0493-38 — the 11-digit billing format is 45802049338. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 17 words ▾

INDICATIONS AND USAGE Ammonium Lactate Cream, 12% is indicated for the treatment of ichthyosis vulgaris and xerosis.

⏱️ Dosage and Administration 21 words ▾

DOSAGE AND ADMINISTRATION Apply to the affected areas and rub in thoroughly. Use twice daily or as directed by a physician.

⛔ Contraindications 21 words ▾

CONTRAINDICATIONS Ammonium Lactate Cream, 12% is contraindicated in those patients with a history of hypersensitivity to any of the label ingredients.

⚠️ Warnings 37 words ▾

WARNING Use of this product should be discontinued if hypersensitivity to any of the ingredients is noted. Sun exposure to areas of the skin treated with ammonium lactate cream should be minimized or avoided (see PRECAUTIONS ).

🤒 Adverse Reactions 89 words ▾

ADVERSE REACTIONS In controlled clinical trials of patients with ichthyosis vulgaris, the most frequent adverse reactions in patients treated with ammonium lactate cream were rash (including erythema and irritation) and burning/stinging. Each was reported in approximately 10-15% of patients. In addition, itching was reported in approximately 5% of patients.

In controlled clinical trials of patients with xerosis, the most frequent adverse reactions in patients treated with ammonium lactate cream were transient burning, in about 3% of patients, stinging, dry skin and rash, each reported in approximately 2% of patients.

🤰 Pregnancy 100 words ▾

Pregnancy: Teratogenic Effects: Pregnancy Category B - Animal reproduction studies have been performed in rats and rabbits at doses up to 0.7 and 1.5 times the human dose, respectively (600 mg/kg/day, corresponding to 3600 mg/m 2 /day in the rat and 7200 mg/m 2 /day in the rabbit) and have revealed no evidence of impaired fertility or harm to the fetus due to ammonium lactate cream. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, ammonium lactate cream should be used during pregnancy only if clearly needed.

🧒 Pediatric Use 23 words ▾

Pediatric Use - The safety and efficacy of Ammonium Lactate Cream, 12% has been established in patients as young as 2 years old.

🧬 Clinical Pharmacology 96 words ▾

CLINICAL PHARMACOLOGY Lactic acid is an alpha-hydroxy acid. It is a normal constituent of tissues and blood. The alpha-hydroxy acids (and their salts) are felt to act as humectants when applied to the skin.

This property may influence hydration of the stratum corneum. In addition, lactic acid, when applied to the skin, may act to decrease corneocyte cohesion. The mechanism(s) by which this is accomplished is not yet known.

An in vitro study of percutaneous absorption of ammonium lactate cream using human cadaver skin indicates that approximately 6.1% of the material was absorbed after 68 hours.

📦 How Supplied / Storage and Handling 40 words ▾

HOW SUPPLIED Ammonium Lactate Cream, 12% is available as follows: 385 g bottle (NDC 45802- 493 -38) STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Manufactured By Padagis Minneapolis, MN 55427 www.padagis.com Rev 11-25 99R38 RC T F1

📦 Storage and Handling 23 words ▾

STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Manufactured By Padagis Minneapolis, MN 55427 www.padagis.com Rev 11-25 99R38 RC T F1

📋 Description 77 words ▾

DESCRIPTION *Ammonium Lactate Cream, 12% is a formulation of 12% lactic acid neutralized with ammonium hydroxide, as ammonium lactate with a pH of 4.4 - 5.4. Ammonium Lactate Cream, 12% also contains cetyl alcohol, glycerin, glyceryl stearate, laureth-4, light mineral oil, magnesium aluminum silicate, methylcellulose, methylparaben, PEG-100 stearate, polyoxyl 40 stearate, propylene glycol, propylparaben, and purified water. Lactic acid is a racemic mixture of 2-hydroxypropanoic acid and has the following structural formula: Ammonium Lactate Cream Structural Formula

💬 Information for Patients 133 words ▾

Information for Patients Patients using ammonium lactate cream should receive the following information and instructions: 1. This medication is to be used as directed by the physician, and should not be used for any disorder other than for which it was prescribed. It is for external use only.

Avoid contact with eyes, lips, or mucous membranes. 2. Patients should minimize or avoid use of this product on areas of the skin that may be exposed to natural or artificial sunlight, including the face.

If sun exposure is unavoidable, clothing should be worn to protect the skin. 3. This medication may cause stinging or burning when applied to skin with fissures, erosions, or abrasions (for example, after shaving the legs).

4. If the skin condition worsens with treatment, the medication should be promptly discontinued.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 45802-0491-84 · Padagis 45802-0495-35 · Padagis →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.