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Salicylic Acid 2% Solution 20 mg/mL Lotion — NDC 72208-0221-01 package photo

Salicylic Acid 2% Solution 20 mg/mL Lotion

by Deciem · 1 BOTTLE, DROPPER in 1 BOX (72208-221-01) / 30 mL in 1 BOTTLE, DROPPER
NDC 72208-0221-01
🏷️ FDA NDC (as labeled) 72208-221-01 billing pads the product segment with a zero
OTC 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) 72208-221-01
Product NDC 72208-221
11-digit billing NDC 72208022101
UNII O414PZ4LPZ
UPC 0769915231731
Application # M006
SPL Set ID 39fa19ee-9cc8-8fbc-e063-6394a90a96df
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-09-09
Route TOPICAL
Dosage form LOTION
Substance SALICYLIC ACID
Why two NDCs? The FDA registers this code as 72208-221-01 — 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 → 72208-0221-01. 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.

🏭 Manufacturer & labeler

LabelerDeciem
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code72208
First marketedSep 2025
Product typeHuman Otc Drug
Portfolio3 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

🧪 What is this product?

This is a topical lotion containing 2% salicylic acid, marketed as an over-the-counter monograph drug. Salicylic acid is a beta-hydroxy acid typically used in skincare products to help remove dead skin cells and unclog pores. It is commonly applied to the skin to address concerns like acne, warts, and other conditions where gentle skin exfoliation may be helpful.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 Not in the retail survey — common for institutional, discontinued, or low-volume packs.
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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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
Acne Cleanser W/ Salicylic Acid 20 mg/mL 62742-4107-01 Allure 177 ml — — FDA listed —
Overnight Clearing 20 mg/mL 68479-0706-00 Dermalogica, 2 ml — — FDA listed —
Cetaphil Gentle Clear Clarifying Acne Cleanser 20 mg/mL 00299-4119-00 Galderma 124 ml — — FDA listed —
Cetaphil Acne Relief Body Wash 20 mg/mL 00299-4121-00 Galderma 591 ml — — FDA listed —
Differin Acne Clearing Body Wash 20 mg/mL 00299-4131-00 Galderma 295 ml — — FDA listed —
Artistry Studio Done With Zit Acne Treatment Clearing Gel 20 mg/mL 10056-0045-00 Access 1 tube — — FDA listed —
Doo Gro Anti-Dandruff Vitalizer 20 mg/mL 12022-0006-00 J. 100 ml — — FDA listed —
Acne Cleansing 20 mg/mL 49527-0045-01 CLINIQUE 1 tube — — FDA listed —
La Roche Posay Laboratorie Dermatologique Effaclar Medicated Cleanser 20 mg/mL 49967-0023-01 L'Oreal 200 ml — — FDA listed —
Garnier Clean Blackhead Eliminating Scrub 20 mg/mL 49967-0035-01 L'Oreal 150 ml — — FDA listed —
Thayers Since 1847 Natural Remedies Blemish Clearing Witch Hazel Aloe Vera Formula Cleanser 20 mg/mL 49967-0051-01 L'Oreal 118 ml — — FDA listed —
CeraVe Developed with Dermatologists Acne Control Cleanser 20 mg/mL 49967-0138-01 L'Oreal 237 ml — — FDA listed —
CeraVe Developed with Dermatologists Acne Control Acne Treatment 20 mg/mL 49967-0172-01 L'Oreal 1 tube — — FDA listed —
Vichy Laboratoires Normaderm Phytoaction Acne Control Daily Moisturizer 20 mg/mL 49967-0606-01 L'Oreal 1 bottle — — FDA listed —
Vichy Laboratoires Normaderm Acne Control Daily Moisturizer 20 mg/mL 49967-0660-01 L'Oreal 1 bottle — — FDA listed —
Dr. Dennis Gross Alpha Beta On the Spot Eliminator 20 mg/mL 51326-0057-01 Topiderm, 1 tube — — FDA listed —
Equate Beauty Quick Action Pads Salicylic Acid Acne Treatment 20 mg/mL 61805-0117-01 Bath 90 patches — — FDA listed —
Vichy Laboratoires Normaderm Acne Control Moisturizer 20 mg/mL 69625-0661-01 COSMETIQUE 1 bottle — — FDA listed —
MILANI ERASE BASE BLEMISH CONTROL PRIMER Salicylic Acid 20 mg/mL 71435-0005-00 New 30 ml — — FDA listed —
Dr. C. Tuna Acne Clear Complexion Cleanser 20 mg/mL 74690-0010-01 Farmasi 1 tube — — FDA listed —
Peach and Lily Peaches Slices Acne Clarifying Cleanser 20 mg/mL 81515-0500-01 Peach 120 ml — — FDA listed —
VANIBISS BUTT and THIGHS Acne Treatment Cream 20 mg/mL 81890-0192-00 Vanibiss 1 jar — — FDA listed —
SIMPLY VITAL Acne Face Cream 20 mg/mL 82460-0272-00 ALPHA 60 ml — — FDA listed —
Skin Laundry. Clean Slate Exfoliating 2 Salicylic Acid Treatment Gel Cleanser Cleanse Exfoliate 20 mg/mL 83727-0294-00 Skin 150 ml — — FDA listed —
Vichy Laboratoires Normaderm Acne Control Daily Moisturizer 20 mg/mL 82046-0617-01 LOreal 1 bottle — — FDA listed —
Skinkure Acne Eraser Spot Treatment 20 mg/mL 83865-0100-10 SKINKURE, 30 ml — — FDA listed —
Acne Scrub 20 mg/mL 41163-0821-99 United 124 ml — — FDA listed —
Acne Scrub 20 mg/mL 49035-0821-99 Walmart 124 ml — — FDA listed —
Thayers Since 1847 Natural Remedies Blemish Clearing Witch Hazel Aloe Vera Formula Balm 20 mg/mL 49967-0530-01 L'Oreal 118 ml — — FDA listed —
Atrix Acne Treatment 20 mg/mL 59088-0446-05 PureTek 59 ml — — FDA listed —
CVS Health Advanced Acne Spot Treatment 20 mg/mL 69842-0464-52 CVS 1 tube — — FDA listed —
Mens Rogaine 2% Salicylic Acid Anti-Dandruff Plus Conditioner 20 mg/mL 69968-0954-02 Kenvue 248 ml — — FDA listed —
Peace Out Acne Moisturizer 20 mg/mL 71494-0008-01 Peace 1 jar — — FDA listed —
Acne Body Wash 20 mg/mL 82575-0110-30 Curology 267 ml — — FDA listed —
Body Wash 20 mg/mL 36800-0354-23 Topco 251 ml — — FDA listed —
IT Cosmetics Bye Bye Breakout Concentrated Derma Serum Acne Treatment 20 mg/mL 49967-0026-01 L'Oreal 1 bottle — — FDA listed —
Walgreens Oil-Free Acne Wash Salicylic Acid 20 mg/mL 00363-3473-01 Walgreen 270 ml — — FDA listed —
Ology Acne Clearing Body Mist 20 mg/mL 00363-9659-10 Walgreens 1 tube — — FDA listed —
amazon basics advanced blemish spot treatment Acne medication 20 mg/mL 72288-0386-01 AMAZON.COM 1 tube — — FDA listed —
The INKEY List C 50 Serum 20 mg/mL 81136-0020-01 Brand 1 bottle — — FDA listed —
Byoma Acne Control Body 20 mg/mL 84821-0004-01 Byoma 400 ml — — FDA listed —
Acne Treatment Gel 20 mg/mL 31720-0301-08 S+ 1 bottle — — FDA listed —
Kiehls Gently Effective Acne Treating Cleansing 20 mg/mL 49967-0464-01 L'Oreal 125 ml — — FDA listed —
Acne Deep Pore Cleansing Wash 20 mg/mL 54108-3700-01 derma 175 ml — — FDA listed —
MDacne Customized Acne Treatment Salicylic Acid 20 mg/mL 71804-0533-00 MDAlgorithms 1 tube — — FDA listed —
Body Wash 20 mg/mL 72288-0353-23 Amazon.com 251 ml — — FDA listed —
Acne Body Wash 20 mg/mL 82575-0200-20 Curology 200 ml — — FDA listed —
Anew Bare Acne Clearing Treatment 2% Salicylic Acid 20 mg/mL 10096-2932-01 THE 1 tube — — FDA listed —
Meijer oil Free Acne Wash Facial Cleanser Pink Grapefruit Acne medication 20 mg/mL 41250-0346-01 Meijer 177 ml — — FDA listed —
Maybelline Dream Pure BB Beauty Balm 20 mg/mL 49967-0957-01 L'Oreal 30 ml — — FDA listed —
DermaClear Serum 20 mg/mL 62742-4069-02 Allure 1 tube — — FDA listed —
Neutrogena Oil Free Acne Wash 20 mg/mL 69968-0516-06 Kenvue 177 ml — — FDA listed —
LEROSETT Botanical Acne Cleanser 20 mg/mL 84463-0507-00 GUNILLA 200 ml — — FDA listed —
Acne Scrub 20 mg/mL 36800-0821-99 Topco 124 ml — — FDA listed —
Meijer Oil Free Acne Wash Pink Grapefruit Foaming Scrub 20 mg/mL 41250-0963-15 MEIJER 198.1 ml — — FDA listed —
ACNE SolutionS CLINICAL ADVANCED CLEARING gel 20 mg/mL 49527-0221-01 CLINIQUE 1 bottle — — Discontinued —
ageLOC LumiSpa Blemish Serum 20 mg/mL 62839-2539-01 NSE 1 bottle — — FDA listed —
WinCo Foods Oil Free Acne Wash with Pink Grapefruit Acne treatment 20 mg/mL 67091-0372-06 WINCO 177 ml — — FDA listed —
Alumier MD Acne Clarifying Cleanser 20 mg/mL 69473-0001-01 Alumier 1 bottle — — FDA listed —
Alumier MD Acne Balancing Serum 20 mg/mL 69473-0002-01 Alumier 1 bottle — — FDA listed —
Salicylic Acid 2% Solution 20 mg/mLthis 72208-0221-01 Deciem 1 bottle — — FDA listed —
Acne Body Wash 20 mg/mL 82575-0100-10 Curology 100 ml — — FDA listed —
Signature Care Oil Free Acne Wash Pink Grapefruit Foaming Scrub 20 mg/mL 21130-0734-15 Safeway, 198 ml — — FDA listed —
Meijer Clarifying Body Wash Acne Treatment 20 mg/mL 41250-0627-01 Meijer 250 ml — — FDA listed —
Daily Meds 20 mg/mL 49825-0100-10 Bioelements, 1 bottle — — FDA listed —
Walgreens Pink Grapefruit Acne Wash 20 mg/mL 00363-0406-15 WALGREEN 198.1 ml — — FDA listed —
Milani Erase Base Blemish Control Primer 20 mg/mL 68577-0103-00 Cosmax 1 tube — — FDA listed —
Neutrogena Oil Free Acne Stress Control Power Clear Scrub 20 mg/mL 69968-0073-04 Kenvue 125 ml — — FDA listed —
Neutrogena Oil-Free Acne Stress Control Power-Cream Wash 20 mg/mL 69968-0519-06 Kenvue 177 ml — — FDA listed —
Clean and Clear Acne Spot Treatment 20 mg/mL 69968-0804-01 Kenvue 1 tube — — FDA listed —
Peace Out Acne Serum 20 mg/mL 71494-0102-30 Peace 1 bottle — — FDA listed —
Acne Scrub 20 mg/mL 72288-0821-99 Amazon.com 124 ml — — FDA listed —
Duolaq 20 mg/mL 87110-0001-01 METHODIQ 1 bottle — — FDA listed —
CeraVe Acne Clay-to-Foam Cleanser 20 mg/mL 49967-0600-01 LOreal 15 tubes — — FDA listed —
Acne Wash 20 mg/mL 55910-0947-30 Old 177 ml — — FDA listed —
Neutrogena Oil-Free Acne Wash Pink Grapefruit Foaming Scrub 20 mg/mL 69968-0247-04 Kenvue 124 ml — — FDA listed —
Neutrogena Rapid Clear Acne Eliminating Spot 20 mg/mL 69968-0825-01 Kenvue 1 tube — — FDA listed —
LBRI PURE n NATURAL KlearAway 20 mg/mL 71238-0464-05 L'BRI 5 ml — — FDA listed —
Tiege Hanley 20 mg/mL 71714-0003-24 Tiege 24 ml — — FDA listed —
pHisoderm CLEAN ANTI-BLEMISH BODY WASH 20 mg/mL 10742-1234-01 The 295 ml — — FDA listed —
pHisoderm CLEAN ANTI-BLEMISH FACIAL CLEANSER 20 mg/mL 10742-1235-01 The 177 ml — — FDA listed —
Oxy Total Care Creamy Facial Cleanser 20 mg/mL 10742-1316-01 The 148 ml — — FDA listed —
Target Up and Up Oil Free Acne Wash Pink Grapefruit Foaming Scrub 20 mg/mL 11673-0068-15 TARGET 198.1 ml — — FDA listed —
Monat Be Clarified Acne-Clearing Moisturizer 20 mg/mL 68577-0107-00 Cosmax 1 bottle — — FDA listed —
Vichy Laboratoires Normaderm Acne Control Daily Moisturizer 20 mg/mL 69625-0617-01 Cosmetique 1 bottle — — FDA listed —
Neutrogena Rapid Clear Acne Eliminating Spot 20 mg/mL 69968-0472-01 Kenvue 1 tube — — FDA listed —
The INKEY List Beta Hydroxy Acid Serum 20 mg/mL 81136-0021-01 Brand 1 bottle — — FDA listed —
Body Wash 20 mg/mL 49035-0073-23 Walmart 250 ml — — FDA listed —
SkinCeuticals Clarifying Exfoliating Cleanser 20 mg/mL 49967-0468-01 L'Oreal 150 ml — — FDA listed —
Gm Collin Puracne 20 mg/mL 64127-0195-01 Laboratoires 1 tube — — FDA listed —
Walgreens Acne Control Gel 20 mg/mL 00363-0269-83 WALGREEN 1 tube — — FDA listed —
Equate 20 mg/mL 79903-0317-68 Walmart 200 ml — — FDA listed —
Acne Free BLACKHEAD REMOVING SCRUB 2 Salicylic Acid with Charcoal 20 mg/mL 80861-0012-01 AcneFree 150 ml — — FDA listed —
The INKEY List Salicylic Acid Cleanser 20 mg/mL 81136-0019-01 Brand 1 bottle — — FDA listed —
Starface Acne Spot Treatment 20 mg/mL 83171-0003-01 Starface 1 tube — — FDA listed —
Byoma Acne Treatment Spot 20 mg/mL 84821-0008-01 Byoma 15 ml — — FDA listed —
Hero Cosmetics Pimple Correct Salicylic Acid Acne Treatment 20 mg/mL 10237-0003-00 Church 1 tube — — FDA listed —
Proactiv Plus Retexturizing Toner 20 mg/mL 11410-0051-00 Alchemee, 1 bottle — — FDA listed —
H.E.B. Oil Free Daily Acne Scrub 20 mg/mL 37808-0342-73 H.E.B 125 ml — — FDA listed —
La Roche Posay Effaclar Medicated Cleanser 20 mg/mL 49967-0402-01 L'Oreal 200 ml — — FDA listed —
CeraVe Developed with Dermatologists Acne Control Cleanser Oil Absorbing Technology 20 mg/mL 49967-0840-01 L'Oreal 473 ml — — FDA listed —
SkinMedica Acne Clarifying Treatment 20 mg/mL 00023-1230-01 Allergan, 1 tube — — FDA listed —
Cetaphil Gentle Clear Pore Clearing Acne Cleanser 20 mg/mL 00299-4143-00 Galderma 237 ml — — FDA listed —
Vichy Laboratoires Normaderm Phytoaction Acne Control Moisturizer 20 mg/mL 69625-0605-01 COSMETIQUE 1 bottle — — FDA listed —
CVS Clarifying Body Wash Acne Treatment 20 mg/mL 69842-0583-01 CVS 250 ml — — FDA listed —
Neutrogena Oil-Free Acne Wash Daily Scrub 20 mg/mL 69968-0075-04 Kenvue 124 ml — — FDA listed —
Clean and Clear Advantage Acne Spot Treatment 20 mg/mL 69968-0126-01 Kenvue 1 tube — — FDA listed —
Neutrogena Oil Free Acne Wash Cleanser 20 mg/mL 69968-0155-06 Kenvue 200 ml — — FDA listed —
Neutrogena Oil Free Acne Wash Pink Grapefruit Foaming Scrub 20 mg/mL 69968-0610-02 Kenvue 59 ml — — FDA listed —
Peace Out Acne Cleanser 20 mg/mL 71494-0103-01 Peace 1 tube — — FDA listed —
Acne Gel Pen 20 mg/mL 71714-0004-01 Tiege 1.3 ml — — FDA listed —
L BRI Klearaway 20 mg/mL 71238-0922-05 L'BRI 5 ml — — FDA listed —
salicylic acid 20 mg/mL 83324-0182-42 Chain 124 ml — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
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

🏛️
2025
On the market since
Sep 2025
📍
2026
Currently FDA-listed
1 year listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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.

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

Medicare Part D (outpatient prescription) spending for Salicylic Acid (matched by generic name) — the program that covers self-administered drugs. 2 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 Salicylic Acid. 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
$11.2K
Claims incl. refills
43
Beneficiaries
35
Spend / beneficiary
$319.01
Spend / claim
$259.66
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 Salicylic Acid 2% Solution (this brand).

Top reported reactions

Vomiting216
Pruritus205
Weight Decreased188
Condition Aggravated184
Urticaria184
Weight Increased183
Hypertension181

Reporter sex

1,855 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Death611
Disabling124
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 154 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 Marketing startStatus
72208-0221-01 You're viewing this 1 BOTTLE, DROPPER in 1 BOX (72208-221-01) / 30 mL in 1 BOTTLE, DROPPER 2025-09-09 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 72208-221-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 72208-0221-01, written without dashes as 72208022101. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 72208-0221-01, the first segment (72208) is the labeler code FDA assigned to Deciem; the middle segment (0221) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Deciem. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Deciem is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 3 words ▾

Indications & Usage

⏱️ Dosage and Administration 3 words ▾

Dosage & Administration

⚠️ Warnings 1 words ▾

Warnings

🧪 Inactive Ingredients 3 words ▾

Inactive Ingredient Section

🎯 Purpose 4 words ▾

OTC - Purpose Section

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 72205-0479-02 · Novadoz 72208-0321-01 · Deciem →
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.