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Ammonium Lactate 120 mg/g Lotion, 225 g — NDC 51672-1300-05 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Ammonium Lactate 120 mg/g Lotion, 225 g — NDC 51672-1300-5 (Billing 51672-1300-05)

by Sun Pharmaceutical Industries, Inc. · 225 g in 1 BOTTLE, PLASTIC

This is a package of 225 g of Ammonium Lactate 120 mg/g Lotion from Sun Pharmaceutical Industries, Inc., marketed since May 2004 and currently FDA-listed; retail pharmacies pay about $0.0732 per g (NADAC). It is the main listing for this product, which comes in 2 package sizes.

NDC 51672-1300-05
🏷️ FDA NDC (as labeled) 51672-1300-5 billing pads the package segment with a zero
This package
Contains225 g Cost per g$0.0732 NADAC Per package$16.47 / 225 g Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.0766/unit · Part D plans $0.0857/unit — full pricing hub ↓
Main listing for product 51672-1300 · Also comes in: 400 g 51672-1300-9
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Aug 13, 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

NDC database record

One package, one record: these facts belong to NDC 51672-1300-5 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
51672 labeler · 1300 product · 5 package
Package marketed since
May 28, 2004
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
225 g per package
Barcode (UPC-A, from the NDC)
3 5167213005 3
Medicaid fills, this package
42,908 prescriptions in the last four reported quarters
FDA record last changed
Aug 13, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 51672-1300-5
Product NDC 51672-1300
11-digit billing NDC 51672130005
NCPDP billing unit GM — per gram (weight)
RxCUI 197362
UNII 67M901L9NQ
Application # ANDA076216
SPL Set ID 8bb09bb3-5bbc-489d-96c1-ae97cb58381e
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 2004-05-28
Route TOPICAL
Dosage form LOTION
Substance AMMONIUM LACTATE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 005826
GCN 20941
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 84:24.04.00
AHFS class Basic Lotions And Liniments
FDB label name AMMONIUM LACTATE 12% LOTION
FDB brand name Ammonium Lactate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 005826
  • GCN: 20941
  • HICL (First Databank): 015560
  • AHFS class code: 84:24.04.00
  • RxCUI (RxNorm): 197362
Why two NDCs? The FDA registers this code as 51672-1300-5 — a 5-4-1 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 package segment → 51672-1300-05. 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.

Clinical

Label name AMMONIUM LACTATE 12% LOTION 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 ↗
📗 Our plain-language guide HelloPharmacist
  • It treats dry, scaly skin (xerosis) and ichthyosis vulgaris, an inherited condition that causes very dry, scaly skin. It can also temporarily ease the itching that comes with these...
  • Shake the bottle well. Then apply it to the affected areas and rub it in thoroughly. Use it twice a day unless your doctor tells you otherwise.
  • The most common ones are skin reactions where you apply it. These include rash, redness, burning, stinging and itching. If they are bothersome or you see signs of an allergic react...
  • Try to limit it. The label advises minimizing or avoiding sun exposure, including tanning beds or lamps, on skin you have treated.
📖 Read our full Ammonium Lactate Topical guide →

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.

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 $0.073 $16.47 / 225 g
Medicaid paysCMS SDUD · 12 mo $0.0766 $17.24 / 225 g
Medicare drug plans payPart D · Q2 2026 $0.0857 $19.28 / 225 g
NADAC price history (per g) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.078 $0.063
▼ Down 3% over the last 24 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.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
51672-1300-05 You're viewing this Main listing 225 g in 1 BOTTLE, PLASTIC $0.0732 / g $16.48 2004-05-28 — Active
51672-1300-09 51672-1300-9 400 g in 1 BOTTLE, PLASTIC $0.0724 / g $28.96 2004-05-28 — Active

You're viewing the smallest of 2 pack sizes for this product.

In Medicaid, this is the most-dispensed pack of this product — about 58% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package contains 225 g — 225 g in 1 bottle, plastic.
How does this package differ from NDC 51672-1300-09?
Both are Ammonium Lactate 120 mg/g Lotion — the drug itself is identical. This page's package is the 225 g one, while NDC 51672-1300-09 is the 400 g package. Per-g NADAC also differs: $0.0732 here vs $0.0724 for the 400 g pack.
What NDC number is used to bill for this package of Ammonium Lactate 120 mg/g Lotion?
Use the 11-digit billing form listed in the identifiers section of this page. 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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ammonium Lactate 120 mg/g 51672-1301-00 Sun 385 g $0.067 AB Availability likely save 9%
Ammonium Lactate 12 g/100g 45802-0419-26 Padagis 400 g $0.072 AB Availability likely save 1%
Ammonium Lactate 120 mg/gthis 51672-1300-05 Sun 225 g $0.073 AB Availability likely —
Ammonium Lactate 120 mg/g 50090-6587-00 A-S 225 g — 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 —
Ammonium Lactate 120 mg/g 70518-3619-00 REMEDYREPACK 2 tubes — AB FDA listed —
Ammonium lactate 120 mg/g 72578-0203-10 Viona 2 tubes — AB FDA listed —
Ammonium lactate 120 mg/g 70771-1988-06 Zydus 2 tubes — 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

🏛️
2004
On the market since
May 2004
📍
2026
Currently FDA-listed
22 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.

What it looks like

Color white
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

🧪 Avoiding an ingredient? See Ammonium Lactate Topical inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 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.

Manufacturer & labeler

LabelerSun Pharmaceutical Industries, Inc.
Application holderSUN PHARMA CANADA INC
FDA applicationANDA076216 (ANDA)
Labeler code51672
First marketedMay 2004
Product typeHuman Prescription Drug
Portfolio891 products on file

More NDCs from Sun Pharmaceutical Industries, Inc. labeler code 51672

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.

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 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 29 words ▾

INDICATIONS AND USAGE Ammonium Lactate Lotion is indicated for the treatment of dry, scaly skin (xerosis) and ichthyosis vulgaris and for temporary relief of itching associated with these conditions.

⏱️ Dosage and Administration 23 words ▾

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

⛔ Contraindications 20 words ▾

CONTRAINDICATIONS Ammonium Lactate Lotion is contraindicated in those patients with a history of hypersensitivity to any of the label ingredients.

⚠️ Warnings 35 words ▾

WARNINGS Sun exposure to areas of the skin treated with Ammonium Lactate Lotion, 12% should be minimized or avoided (see PRECAUTIONS section). The use of Ammonium Lactate Lotion should be discontinued if hypersensitivity is observed.

🤒 Adverse Reactions 95 words ▾

ADVERSE REACTIONS The most frequent adverse experiences in patients with xerosis are transient stinging (1 in 30 patients), burning (1 in 30 patients), erythema (1 in 50 patients) and peeling (1 in 60 patients). Other adverse reactions which occur less frequently are irritation, eczema, petechiae, dryness and hyperpigmentation. Due to the more severe initial skin conditions associated with ichthyosis, there was a higher incidence of transient stinging, burning and erythema (each occurring in 1 in 10 patients).

To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc., at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

🤰 Pregnancy 96 words ▾

Pregnancy Teratogenic effects 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 formulations. 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 Lotion should be used during pregnancy only if clearly needed.

🧒 Pediatric Use 22 words ▾

Pediatric Use Safety and effectiveness of Ammonium Lactate Lotion have been demonstrated in infants and children. No unusual toxic effects were reported.

🧓 Geriatric Use 55 words ▾

Geriatric Use Clinical studies of Ammonium Lactate Lotion 12% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious.

🆘 Overdosage 23 words ▾

OVERDOSAGE The oral administration of Ammonium Lactate Lotion to rats and mice showed this drug to be practically non-toxic (LD 50 >15 mL/kg).

🧬 Clinical Pharmacology 94 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) may 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 Lotion using human cadaver skin indicates that approximately 5.8% of the material was absorbed after 68 hours.

📦 How Supplied / Storage and Handling 28 words ▾

HOW SUPPLIED 225 g (NDC 51672-1300-5) plastic bottle and 400 g (NDC 51672-1300-9) plastic bottle. Store between 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

📦 Storage and Handling 13 words ▾

Store between 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

📋 Description 76 words ▾

DESCRIPTION *Ammonium Lactate Lotion, 12% specially formulates 12% lactic acid, as ammonium lactate to provide a lotion pH of 4.5 to 5.5. Ammonium Lactate Lotion also contains cetyl alcohol, glycerin, glyceryl monostearate, laureth-4, light mineral oil, magnesium aluminum silicate, methylcellulose, methylparaben, polyoxyethylene 100 stearate, polyoxyl stearate type II, propylene glycol, propylparaben, purified water, and for pH adjustment: lactic acid. Lactic acid is a racemic mixture of 2-hydroxypropanoic acid and has the following structural formula: Chemical Structure

💬 Information for Patients 131 words ▾

Information for Patients Patients using Ammonium Lactate Lotion, 12% should receive the following information and instructions: 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.

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. This medication may cause transient stinging or burning when applied to skin with fissures, erosions, or abrasions (for example, after shaving the legs).

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

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General For external use only. Stinging or burning may occur when applied to skin with fissures, erosions or that is otherwise abraded (for example, after shaving the legs). Caution is advised when used on the face because of the potential for irritation.

The potential for post-inflammatory hypo- or hyperpigmentation has not been studied. Information for Patients Patients using Ammonium Lactate Lotion, 12% should receive the following information and instructions: 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. 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.

This medication may cause transient stinging or burning when applied to skin with fissures, erosions, or abrasions (for example, after shaving the legs). If the skin condition worsens with treatment, the medication should be promptly discontinued. Carcinogenesis, Mutagenesis, Impairment of Fertility The topical treatment of CD-1 mice with 12%, 21% or 30% ammonium lactate formulations for two years did not produce a significant increase in dermal or systemic tumors in the absence of increased exposure to ultraviolet radiation.

The maximum systemic exposure of the mice in this study was 0.7 times the maximum possible systemic exposure in humans. However, a long-term photocarcinogenicity study in hairless albino mice suggested that topically applied 12% ammonium lactate formulations enhanced the rate of ultraviolet light-induced skin tumor formation. The mutagenic potential of ammonium lactate formulations was evaluated in the Ames assay and in the mouse in vivo micronucleus assay, both of which were negative.

In dermal Segment I and III studies with ammonium lactate formulations there were no effects observed in fertility or pre- or post-natal development parameters in rats at dose levels of 300 mg/kg/day (1800 mg/m 2 /day), approximately 0.4 times the human topical dose. Pregnancy Teratogenic effects 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 formulations.

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 Lotion should be used during pregnancy only if clearly needed. Nursing Mothers Although lactic acid is a normal constituent of blood and tissues, it is not known to what extent this drug affects normal lactic acid levels in human milk.

Because many drugs are excreted in human milk, caution should be exercised when Ammonium Lactate Lotion is administered to a nursing woman. Pediatric Use Safety and effectiveness of Ammonium Lactate Lotion have been demonstrated in infants and children. No unusual toxic effects were reported.

Geriatric Use Clinical studies of Ammonium Lactate Lotion 12% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious.

🍼 Nursing Mothers 52 words ▾

Nursing Mothers Although lactic acid is a normal constituent of blood and tissues, it is not known to what extent this drug affects normal lactic acid levels in human milk. Because many drugs are excreted in human milk, caution should be exercised when Ammonium Lactate Lotion is administered to a nursing woman.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 157 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility The topical treatment of CD-1 mice with 12%, 21% or 30% ammonium lactate formulations for two years did not produce a significant increase in dermal or systemic tumors in the absence of increased exposure to ultraviolet radiation. The maximum systemic exposure of the mice in this study was 0.7 times the maximum possible systemic exposure in humans. However, a long-term photocarcinogenicity study in hairless albino mice suggested that topically applied 12% ammonium lactate formulations enhanced the rate of ultraviolet light-induced skin tumor formation.

The mutagenic potential of ammonium lactate formulations was evaluated in the Ames assay and in the mouse in vivo micronucleus assay, both of which were negative. In dermal Segment I and III studies with ammonium lactate formulations there were no effects observed in fertility or pre- or post-natal development parameters in rats at dose levels of 300 mg/kg/day (1800 mg/m 2 /day), approximately 0.4 times the human topical dose.

📄 Package Label / Principal Display Panel 117 words ▾

PRINCIPAL DISPLAY PANEL - 225 g Bottle Label NDC 51672-1300-5 225 g Ammonium Lactate Lotion 12%* CONTAINS: *Ammonium lactate equivalent to 12% lactic acid, cetyl alcohol, glycerin, glyceryl monostearate, laureth-4, light mineral oil, magnesium aluminum silicate, methylcellulose, methylparaben, polyoxyethylene 100 stearate, polyoxyl stearate type II, propylene glycol, propylparaben, purified water, and for pH adjustment: lactic acid. For Dermatologic Use Only. Not for Ophthalmic, Oral or Intravaginal Use.

See package insert for full prescribing information. Store at controlled room temperature 20° to 25°C (68° to 77°F). For lot number and expiry date see below.

Mfd. by: Sun Pharma Canada Inc. Brampton, Ontario, Canada L6T 1C1 Dist. by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 5265724 Rx only label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
42.9K
Units reimbursed last 4 qtrs
9.7M
Gross reimbursed last 4 qtrs
$743.3K
Avg / prescription
$17.32
Avg / unit
$0.0766
Latest quarter Q1 2026
10.5KRx
Medicaid pays / g
$0.0766
gross reimbursed
vs
NADAC / g
$0.0732
acquisition cost
=
Spread
+$0.0034
+5% vs cost
What Medicaid paid per g (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
17% FFS 83% MCO
Fee-for-service · 7,224 Rx Managed care · 35,684 Rx
State Medicaid map
Alaska: no data reported AK Maine: 32,175 units · 2,306 per 100k residents ME Washington: 49,500 units · 634 per 100k residents WA Idaho: no data reported ID Montana: 2,475 units · 219 per 100k residents MT North Dakota: no data reported ND Minnesota: 112,463 units · 1,960 per 100k residents MN Wisconsin: 96,473 units · 1,632 per 100k residents WI Michigan: 3,004,513 units · 29,934 per 100k residents MI New York: 24,751 units · 126 per 100k residents NY Vermont: no data reported VT New Hampshire: 2,700 units · 193 per 100k residents NH Oregon: no data reported OR Nevada: 140,843 units · 4,410 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 29,250 units · 912 per 100k residents IA Illinois: 348,125 units · 2,774 per 100k residents IL Indiana: 74,251 units · 1,082 per 100k residents IN Ohio: 816,267 units · 6,926 per 100k residents OH Pennsylvania: 811,532 units · 6,261 per 100k residents PA New Jersey: 966,607 units · 10,405 per 100k residents NJ Massachusetts: 112,007 units · 1,600 per 100k residents MA California: no data reported CA Utah: 5,850 units · 171 per 100k residents UT Colorado: 63,168 units · 1,075 per 100k residents CO Nebraska: 9,000 units · 455 per 100k residents NE Missouri: no data reported MO Kentucky: 223,224 units · 4,932 per 100k residents KY West Virginia: 66,150 units · 3,737 per 100k residents WV Virginia: 121,083 units · 1,389 per 100k residents VA Maryland: 128,528 units · 2,080 per 100k residents MD Connecticut: 414,000 units · 11,446 per 100k residents CT Rhode Island: 47,250 units · 4,315 per 100k residents RI Arizona: 80,332 units · 1,081 per 100k residents AZ New Mexico: no data reported NM Kansas: 6,300 units · 214 per 100k residents KS Arkansas: 6,300 units · 205 per 100k residents AR Tennessee: 132,750 units · 1,863 per 100k residents TN North Carolina: 151,859 units · 1,402 per 100k residents NC South Carolina: 34,876 units · 649 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 337,797 units · 7,385 per 100k residents LA Mississippi: no data reported MS Alabama: 19,525 units · 382 per 100k residents AL Georgia: 124,353 units · 1,128 per 100k residents GA D.C.: 68,924 units · 10,151 per 100k residents DC Hawaii: 2,925 units · 204 per 100k residents HI Texas: 509,649 units · 1,671 per 100k residents TX Florida: 531,123 units · 2,349 per 100k residents FL
Units reimbursed · per 100k residents
12629,934
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Michigan 29,934 /100k
2 Connecticut 11,446 /100k
3 New Jersey 10,405 /100k
4 D.C. 10,151 /100k
5 Louisiana 7,385 /100k
6 Ohio 6,926 /100k
7 Pennsylvania 6,261 /100k
8 Kentucky 4,932 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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.
225 g this page51672-1300-05 42,908 Rx · $743,261
400 g51672-1300-09 30,777 Rx · $687,364
Drug total (last 4 qtrs): 73,685 Rx · 19,122,348 units · $1,430,625 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.
← 51672-1298-01 · Sun 51672-1301-00 · Sun →
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.