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DOCOSANOL 100 mg/g Cream — NDC 00536-1427-04 package photo

DOCOSANOL 100 mg/g Cream

by Rugby Laboratories · 1 TUBE in 1 PACKAGE (0536-1427-04) / 2 g in 1 TUBE
NDC 00536-1427-04
🏷️ FDA NDC (as labeled) 0536-1427-04 billing pads the labeler segment with a zero
OTC 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) 0536-1427-04
Product NDC 0536-1427
11-digit billing NDC 00536142704
NCPDP billing unit GM — per gram (weight)
RxCUI 797534
UNII 9G1OE216XY
Application # ANDA215839
SPL Set ID 6f8d6375-8188-42e9-a048-e8a554122ff3
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-05-22
Route TOPICAL
Dosage form CREAM
Substance DOCOSANOL
GPI-14 90350022003720
GCN Seq No 047524
GCN 12866
HICL code 021956
Ingredient (HICL) Docosanol
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q5
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin
HIC3 code Q5V
Therapeutic class — specific (HIC3) Topical Antivirals
AHFS code 84:04.06.00
AHFS class Antivirals (Skin And Mucous Membrane)
FDB label name DOCOSANOL 10% CREAM
FDB brand name Docosanol
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 0536-1427-04 — a 4-4-2 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 labeler segment → 00536-1427-04. 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 Antivirals class.

Drug family (ATC) Antivirals
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

LabelerRugby Laboratories
Application holderALEMBIC PHARMACEUTICALS LTD
FDA applicationANDA215839 (ANDA)
Labeler code00536
First marketedMay 2024
Product typeHuman Otc Drug
Portfolio149 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 DOCOSANOL 10% CREAM Ingredient Docosanol
📗 Our plain-language guide HelloPharmacist
  • Docosanol cream treats cold sores and fever blisters on the face or lips. It's designed to shorten how long the sore lasts and reduce those uncomfortable symptoms — the tingling, p...
  • What exactly does docosanol do for a cold sore?
  • You apply it 5 times a day, every day, until the sore is completely healed. Don't stop early just because it looks better — keep going until it's fully healed. And remember to wash...
  • How often do I need to apply it, and for how long?
📖 Read our full Docosanol guide →

Supplement & herbal interactions

Some supplements/herbs that may interact with Docosanol — tap one for details:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Docosanol (3 interactions) — ranked by severity →
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.

💊 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.

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

  • UNII LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • 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 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 33X4X4B90S
    Sucrose distearate is an emulsifier made from sugar and stearic acid. It helps mix oil and water-based ingredients together and improves the texture and stability of the medicine.
  • UNII 274KW0O50M
    Sucrose stearate is a compound made from sugar and stearic acid (a fatty substance). It works as an emulsifier and surfactant to help mix oils and water-based ingredients together in the medicine.
  • 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.

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

The official label also statesbenzyl alcohol, light mineral oil, propylene glycol, purified water, sucrose distearate, sucrose stearate

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

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 $6.206 $12.41 / 2 g
Medicaid paysCMS SDUD · 12 mo $10.60 $21.20 / 2 g
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per g) — tap or hover for the price & month
Dec 2025 Feb 2026 May 2026 Aug 2026 $6.817 $6.206
▼ Down 7% over the last 9 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
Docosanol 100 mg/g 62011-0433-01 Strategic 1 tube $5.946 — FDA listed save 4%
Docosanol 100 mg/gthis 00536-1427-04 Rugby 1 tube $6.206 — Availability likely —
Docosanol 100 mg/g 00713-0353-02 Cosette 1 tube $6.206 — Availability likely —
Docosanol 100 mg/g 46122-0800-36 Amerisource 1 tube $6.206 — Availability likely —
Docosanol 100 mg/g 51672-1406-02 Sun 2 tubes $6.206 — Availability likely —
Docosanol 100 mg/g 61269-0881-35 H2-Pharma, 2 g $6.206 — Availability likely —
Docosanol 100 mg/g 61269-0989-37 H2-Pharma, 1 bottle $6.206 — Availability likely —
Docosanol 100 mg/g 70000-0672-01 Leader/ 1 tube $6.206 — Availability likely —
Cold Sore Fever Blister Treatment 100 mg/g 70677-1255-01 Strategic 1 tube $6.206 — Availability likely —
Abreva 100 mg/g 00135-0200-01 Haleon 2 g — — FDA listed —
Abreva 100 mg/g 00135-0300-01 Haleon 1 tube — — FDA listed —
Cold Sore Fever Blister Treatment 100 mg/g 00363-6510-07 Walgreens 2 g — — FDA listed —
Cold Sore Fever Blister Treatment 100 mg/g 00363-8877-07 Walgreens 2 g — — FDA listed —
Docosanol 100 mg/g 00363-8980-07 Walgreens 1 tube — — FDA listed —
Cold Sore Fever Blister Treatment 100 mg/g 00363-9220-07 Walgreens 1 tube — — FDA listed —
Cold Sore Fever Blister Treatment 100 mg/g 00363-9222-07 Walgreens 1 tube — — FDA listed —
Cold Sore Treatment Docosanol 100 mg/g 10157-2124-02 Blistex 1 tube — — FDA listed —
Cold Sore Fever Blister Treatment 100 mg/g 11673-0769-14 TARGET 2 tubes — — FDA listed —
Cold Sore Fever Blister Treatment 100 mg/g 11673-0846-14 TARGET 2 tubes — — FDA listed —
Docosanol 100 mg/g 21130-0422-07 Safeway, 1 tube — — FDA listed —
Cold Sore Fever Blister Treatment 100 mg/g 21130-0605-07 Safeway, 2 g — — FDA listed —
Docosanol 100 mg/g 21130-0770-07 Safeway, 1 tube — — FDA listed —
Cold Sore Fever Blister Treatment 100 mg/g 21130-0823-07 Safeway, 1 tube — — FDA listed —
Docosanol 100 mg/g 21922-0023-17 Encube 1 bottle — — FDA listed —
Docosanol 100 mg/g 30142-0286-02 KROGER 1 tube — — FDA listed —
Cold Sore Fever Blister 100 mg/g 30142-0322-07 The 1 tube — — Discontinued —
Cold Sore Fever Blister Treatment 100 mg/g 30142-0869-07 The 2 g — — FDA listed —
Cold Sore Fever Blister Treatment 100 mg/g 30142-0981-07 The 1 tube — — FDA listed —
Cold Sore Fever Blister 100 mg/g 37808-0223-07 H 1 tube — — FDA listed —
Cold Sore Treatment 100 mg/g 37808-0229-07 H 1 tube — — FDA listed —
Cold Sore Fever Blister 100 mg/g 37808-0661-07 H 1 tube — — FDA listed —
Cold Sore Fever Blister Treatment 100 mg/g 37808-0765-07 H 2 g — — FDA listed —
Docosanol 100 mg/g 41163-0724-07 United 1 tube — — FDA listed —
Docosanol 100 mg/g 41250-0867-07 MEIJER, 1 tube — — FDA listed —
Docosanol 100 mg/g 41415-0660-03 Publix 1 tube — — FDA listed —
Docosanol 100 mg/g 46708-0682-01 Alembic 1 tube — — FDA listed —
Docosanol 100 mg/g 49035-0259-35 EQUATE 1 tube — — FDA listed —
Docosanol 100 mg/g 51316-0763-02 CVS 1 tube — — FDA listed —
Docosanol 100 mg/g 55301-0112-07 AAFES/Your 1 tube — — FDA listed —
Docosanol 100 mg/g 55301-0877-07 AAFES/Your 1 tube — — FDA listed —
Docosanol 100 mg/g 55319-0922-07 Family 1 tube — — FDA listed —
Cold Sore Fever Blister Treatment 100 mg/g 55910-0550-07 Dolgencorp, 2 g — — FDA listed —
Cold Sore Fever Blister Treatment 100 mg/g 55910-0859-07 Dolgencorp, 1 tube — — FDA listed —
Cold Sore Fever Blister Treatment 100 mg/g 55910-0963-07 Dolgencorp, 1 tube — — FDA listed —
Docosanol 100 mg/g 58602-0019-08 Aurohealth 1 tube — — FDA listed —
Cold Sore Treatment 100 mg/g 59726-0112-07 P 1 tube — — FDA listed —
Cold Sore Fever Blister 100 mg/g 59726-0221-07 P 1 tube — — FDA listed —
Cold Sore Fever Blister Treatment 100 mg/g 59726-0877-07 P 2 g — — FDA listed —
Cold Sore Treatment 100 mg/g 59726-0922-07 P 1 tube — — FDA listed —
Cold Sore Treatment 100 mg/g 59726-0924-07 P 1 tube — — FDA listed —
Docosanol 100 mg/g 62332-0682-01 Alembic 1 tube — — FDA listed —
Docosanol 100 mg/g 63941-0922-07 Best 1 tube — — FDA listed —
Cold Sore Fever Blister Treatment 100 mg/g 68016-0344-07 Chain 1 tube — — FDA listed —
Docosanol 100 mg/g 70000-0743-01 Leader/ 1 bottle — — FDA listed —
Amazon Basics Docosanol 100 mg/g 72288-0006-01 Amazon.com 1 tube — — FDA listed —
Docosanol 100 mg/g 72476-0492-07 Care 1 tube — — FDA listed —
Docosanol 100 mg/g 72476-0922-07 Care 1 tube — — FDA listed —
Docosanol 100 mg/g 72476-0965-07 Care 1 tube — — FDA listed —
Docosanol 100 mg/g 73581-0004-02 YYBA 2 tubes — — FDA listed —
Cold Sore Fever Blister Treatment 100 mg/g 76162-0818-07 Topco 1 tube — — FDA listed —
Cold Sore Fever Blister Treatment 100 mg/g 76162-0900-07 Topco 1 tube — — FDA listed —
Cold Sore Fever Blister Treatment 100 mg/g 79481-0065-07 Meijer 2 g — — FDA listed —
Cold Sore Fever Blister Treatment 100 mg/g 79481-9220-07 Meijer 2 tubes — — FDA listed —
Docosanol 100 mg/g 79903-0011-07 WALMART 1 tube — — FDA listed —
Docosanol 100 mg/g 79903-0118-14 WALMART 2 tubes — — FDA listed —
Cold Sore Fever Blister Treatment 100 mg/g 79903-0248-07 WALMART 1 tube — — FDA listed —
Docosanol 100 mg/g 79903-0402-10 WALMART 1 tube — — FDA listed —
Cold Sore Fever Blister Treatment 100 mg/g 79903-0435-00 WALMART 2 g — — FDA listed —
Cold Sore Fever Blister Treatment 100 mg/g 81522-0112-07 FSA 1 tube — — FDA listed —
Cold Sore Treatment 100 mg/g 81522-0922-07 FSA 1 tube — — FDA listed —
Cold Sore Fever Blister Treatment 100 mg/g 81522-0923-07 FSA 1 tube — — FDA listed —
Julie Cold Sore Treatment 100 mg/g 82791-0362-01 Julie 2 g — — FDA listed —
Cold Sore Fever Blister Treatment 100 mg/g 85766-0239-02 Sportpharm 1 tube — — FDA listed —
Docosanol 100 mg/g 84725-0001-01 KLM 1 tube — — 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

🏛️
2024
On the market since
May 2024
📍
2026
Currently FDA-listed
2 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 & 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 00536-1427-04, 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 – Q4 2025 · 4 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
1.6K
Units reimbursed last 4 qtrs
3.3K
Gross reimbursed last 4 qtrs
$35.1K
Avg / prescription
$21.71
Avg / unit
$10.5980
Latest quarter Q4 2025
334Rx
Medicaid pays / g
$10.5980
gross reimbursed
vs
NADAC / g
$6.2060
acquisition cost
=
Spread
+$4.3920
+71% 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 ⓘ
72% FFS 28% MCO
Fee-for-service · 1,160 Rx Managed care · 458 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 62 units · 0.6 per 100k residents MI New York: 2,066 units · 10.6 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 298 units · 2.5 per 100k residents OH Pennsylvania: 162 units · 1.2 per 100k residents PA New Jersey: 442 units · 4.8 per 100k residents NJ Massachusetts: no data reported MA California: 262 units · 0.7 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 22 units · 0.5 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.510.6
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 New York 10.6 /100k
2 New Jersey 4.8 /100k
3 Ohio 2.5 /100k
4 Pennsylvania 1.2 /100k
5 California 0.7 /100k
6 Michigan 0.6 /100k
7 Kentucky 0.5 /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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00536-1427-04 You're viewing this 1 TUBE in 1 PACKAGE (0536-1427-04) / 2 g in 1 TUBE 2024-05-22 Active

📄 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 23 words ▾

Uses treats cold sores/fever blisters on the face or lips shortens healing time and duration of symptoms: • tingling, pain, burning, and/or itching

⏱️ Dosage and Administration 13 words ▾

Other information store at 20° to 25°C (68° to 77°F) do not freeze

⚠️ Warnings 109 words ▾

Warnings Allergy Alert This product may cause a severe allergic reaction. Symptoms may include: hives facial swelling wheezing/difficulty breathing shock rash If an allergic reaction occurs, stop use and seek medical help right away. For external use only Do not use if you are allergic to any ingredient in this product When using this product apply only to the affected areas do not use in or near the eyes avoid applying directly inside your mouth do not share this product with anyone.

This may spread the infection. Stop use and ask a doctor if your cold sore gets worse or the cold sore is not healed within 10 days

🧪 Active Ingredient 4 words ▾

Active ingredient Docosanol 10%

🧪 Inactive Ingredients 15 words ▾

Inactive ingredients benzyl alcohol, light mineral oil, propylene glycol, purified water, sucrose distearate, sucrose stearate

🎯 Purpose 5 words ▾

Purpose Cold sore/fever blister treatment

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00536-1426-77 · Rugby 00536-1430-97 · Rugby →
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.