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Diaper Rash Cream Zinc Oxide 15 g/100g Cream, 85 g — NDC 83369-0002-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Diaper Rash Cream Zinc Oxide 15 g/100g Cream, 85 g — NDC 83369-002-01 (Billing 83369-0002-01)

by Smalls Brand LLC DBA Roe Wellness · 85 g in 1 CARTON

This is a package of 85 g of Diaper Rash Cream Zinc Oxide 15 g/100g Cream from Smalls Brand LLC DBA Roe Wellness, marketed since Feb 2026 and currently FDA-listed. It is this product's only package size.

NDC 83369-0002-01
🏷️ FDA NDC (as labeled) 83369-002-01 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 83369-002-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
83369 labeler · 002 product · 01 package
Package marketed since
Feb 27, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 8336900201 5
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Zinc Oxide (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0212-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0206-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0202-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0207-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0209-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0208-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 83369-002-01
Product NDC 83369-002
11-digit billing NDC 83369000201
RxCUI 245660
UNII SOI2LOH54Z
Application # M016
SPL Set ID 4bd29285-29b4-5d57-e063-6294a90af481
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-02-27
Route TOPICAL
Dosage form CREAM
Substance ZINC OXIDE
Quick answers
  • RxCUI (RxNorm): 245660
Why two NDCs? The FDA registers this code as 83369-002-01 — 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 → 83369-0002-01. 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.

Clinical

🧪 What is this product?

This is a topical cream containing zinc oxide 15%, marketed as an over-the-counter diaper rash product under FDA's monograph rules for skin protectants. Zinc oxide is commonly used in diaper rash creams to form a protective barrier on the skin and help reduce moisture contact with irritated areas. The cream is applied directly to the skin in the diaper area.

Supplement & herbal interactions

Some supplements/herbs that may interact with Zinc oxide (OTC drug) — tap one for details:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Zinc oxide (OTC drug) (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.

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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
83369-0002-01 You're viewing this Main listing 85 g in 1 CARTON 2026-02-27 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Aquaphor Healing Diaper Rash 15 g/100g 10356-0105-02 Beiersdorf 7 g — — FDA listed —
Attitude Diaper Cream Zinc Unscented 15 g/100g 61649-0260-01 9055-7588 30 g — — FDA listed —
ZOEY NATURALS DIAPER Cream 15 g/100mL 70793-0010-34 Absolutely 1 tube — — FDA listed —
Diaper Rash Cream 15 g/100gthis 83369-0002-01 Smalls 85 g — — FDA listed —
Elta MD UV AOX Eye 15 g/100g 72043-4342-01 CP 1 tube — — FDA listed —
Impeccable Skin Moisturizing Face Sunscreen Broad Spectrum SPF 30 15 g/100g 56152-0100-01 Cosmetic 56.7 g — — FDA listed —
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Tan 15 g/100g 56152-0260-01 Cosmetic 7.1 g — — FDA listed —
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Buff 15 g/100g 56152-0259-01 Cosmetic 7.1 g — — FDA listed —
Hawaiian Tropic Mineral Skin Nourishing Milk Sunscreen Broad Spectrum SPF 30 15 g/100g 63354-0421-12 Edgewell 100 g — — FDA listed —
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Mocha 15 g/100g 56152-0264-01 Cosmetic 7.1 g — — FDA listed —
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Ivory 15 g/100g 56152-0263-01 Cosmetic 7.1 g — — FDA listed —
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Nude 15 g/100g 56152-0261-01 Cosmetic 7.1 g — — FDA listed —
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Sand 15 g/100g 56152-0258-01 Cosmetic 7.1 g — — FDA listed —
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Bronze 15 g/100g 56152-0262-01 Cosmetic 7.1 g — — 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

🏛️
2026
On the market since
Feb 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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.

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 TR046Y3K1G
    A liquid alcohol derived from petroleum or plant sources. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII 3SCV180C9W
    Betaine is a naturally occurring organic compound found in plants and animals. In medicines, it acts as an osmoprotectant and stabilizer, helping maintain the product's moisture balance and preserve its chemical stability during storage.
  • UNII TY3J98ZR7R
    A synthetic polymer that acts as a film-former and texture enhancer in topical formulations. It helps create a smooth, long-wearing coating on skin and improves how the product spreads and adheres.
  • UNII 114P5I43UJ
    A hydrocarbon oil derived from petroleum, containing 13 to 15 carbon atoms per molecule. It serves as a lubricant and glidant in tablets and capsules to reduce friction during manufacturing and improve powder flow.
  • UNII C9H2L21V7U
    A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
  • UNII 00YIU5438U
    Caprylyl glycol is a clear liquid derived from coconut oil. In medicines, it acts as a humectant to retain moisture, a preservative booster to prevent microbial growth, and a solvent to help dissolve or mix other ingredients.
  • UNII ISE9I7DNUG
    Cocoglycerides are fatty substances derived from coconut oil. They act as emulsifiers and solubilizers in medicines, helping blend water and oil-based ingredients together and improve how the body absorbs certain drugs.
  • UNII X687XDK09L
    A clay mineral processed to carry positive charges, used as a thickener and suspending agent in liquid medicines. It helps keep solid particles evenly distributed throughout the product.
  • UNII 1Z74184RGV
    Egg phospholipids are naturally derived fats from eggs that help mix oil and water-based ingredients together. They work as emulsifiers in medicines, keeping the formula stable and uniform.
  • UNII HTC7G3S2PV
    Ethylhexyl olivate is an emollient and skin-conditioning agent derived from olive oil. It helps soften the product's texture and improves how the medicine spreads or absorbs on skin or mucous membranes.
  • 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 ZF94AP8MEY
    Hydrogenated castor oil is a processed plant oil made by adding hydrogen to castor oil. It's used as a binder to help hold tablet ingredients together and as a lubricant to prevent sticking during manufacturing.
  • UNII G1L3HT4CMH
    A synthetic compound used in medicines as a preservative and antimicrobial agent. It helps prevent bacterial and fungal growth, extending the product's shelf life.
  • UNII 7F0EV20QYL
    Jojoba oil is a liquid wax extracted from jojoba plant seeds. In medications, it serves as an emollient and carrier oil that helps soften skin, improve texture, and distribute active ingredients evenly in topical formulations.
  • UNII 24WE03BX2T
    Levomenol is a naturally derived alcohol compound used as a skin-conditioning and anti-inflammatory agent in topical formulations. It helps soothe and protect the skin while improving product texture and absorption.
  • UNII 9KJL21T0QJ
    Linoleic acid is an omega-6 fatty acid derived from plant oils. It serves as an emulsifier and skin conditioning agent in topical formulations, helping ingredients mix smoothly and improving product texture.
  • UNII 0RBV727H71
    A natural fatty acid derived from plant oils. It helps dissolve other ingredients and improve how the medicine spreads or absorbs in the body.
  • UNII 3HH93SL2H9
    A plant-derived oil made from meadowfoam seeds. It acts as an emollient and lubricant in medicines, helping soften formulations and improve how ingredients mix together.
  • UNII Z6J799EAJK
    Oat is a cereal grain used in medicines as a filler and binder. It helps give the medication its shape and structure while adding bulk to the formulation.
  • UNII 71M78END5S
    A natural fat derived from fish or algae sources. It's included as a nutritional ingredient and helps distribute other components evenly throughout the medicine.
  • UNII WV9CM0O67Z
    Panthenol is a humectant and skin-conditioning agent derived from pantothenic acid. It's added to medicines to help retain moisture and soothe skin irritation.
  • UNII 7Q0OK5DOT4
    A plant-derived emulsifier made from glycerin and ricinoleic acid (from castor oil). It helps blend oil and water-based ingredients together in formulations and improves product texture and stability.
  • UNII 5965N8W85T
    Propanediol is a clear liquid organic compound derived from vegetable sources or synthesized chemically. It acts as a humectant to retain moisture, a solvent to dissolve active ingredients, and a preservative booster in liquid medications and supplements.
  • UNII B423VGH5S9
    A natural fruit ingredient derived from apples, used as a flavoring agent and sweetener to improve taste and palatability of the medicine.
  • UNII 6RG2461FCH
    A natural plant-based wax derived from the fruit rind of Toxicodendron vernicifluum (Chinese lacquer tree). Used as a coating agent and lubricant to provide a smooth surface on tablets or capsules and improve handling during manufacturing.
  • UNII K49155WL9Y
    Shea butter is a fat extracted from shea tree nuts. It's used in medicines as an emollient and lubricant to soften the product, improve texture, and help ingredients blend smoothly together.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • UNII 8W46YN971G
    Sodium dehydroacetate is a salt derived from dehydroacetic acid, a compound used as a preservative. It helps prevent mold, bacteria, and yeast growth in medicines, extending shelf life and maintaining product safety.
  • UNII GW89575KF9
    Squalane is a lightweight oil derived from plant sources or synthesized. It acts as an emollient and lubricant in formulations, helping ingredients blend smoothly and improving product texture and spreadability.
  • UNII 3YYE6VJS0P
    A compound derived from licorice root extract combined with stearyl alcohol. It acts as an emollient and skin-conditioning agent that helps soften and smooth the product's texture while providing a protective barrier on the skin or mucous membranes.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • UNII 5EHL50I4MY
    A sodium salt compound used as a chelating agent in medicines. It binds to metals and minerals to improve stability, prevent discoloration, and help the medication stay effective longer.
  • UNII R0ZB2556P8
    Tocopherol is a form of vitamin E derived from plant oils. It acts as an antioxidant in medicines to prevent oils and fats from breaking down and spoiling 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.

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

The official label also statesWater, Caprylic/Capric Triglyceride, Glycerin. C13-15 Alkane, Ethylhexyl Olivate, Propanediol, Polyglyceryl-3 Polyricinoleate, Bis-Octyldodecylhexyl Dimer Dilinoleate/Propanediol Copolymer, Cocoglycerides, Meadowfoam Estolide, Disteardimonium Hectorite, Jojoba Esters, Hydrogenated Castor Oil, Lactococcus Ferment Lysate, Rhus Verniciflua Peel Wax, Squalane, 1,2-Hexanediol, Butyrospermum Parkii (Shea) Butter, Caprylyl Glycol, Pyrus Malus (Apple) Fruit Extract, Sodium Chloride, Linoleic Acid, Betaine, Sucrose, Hydroxyacetophenone, Phospholipids, Phytosterols, Sodium Citrate, Hydrolyzed Rhodophyceae Extract, Bisabolol, Panthenol, Sodium Dehydroacetate, Stearyl Glycyrrhetinate, Tocopherol, Tetrasodium Glutamate Diacetate, Linolenic Acid, Avena Sativa (Oat) Kernel Extract.

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.

Manufacturer & labeler

LabelerSmalls Brand LLC DBA Roe Wellness
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code83369
First marketedFeb 2026
Product typeHuman Otc Drug
Portfolio4 products on file

More NDCs from Smalls Brand LLC DBA Roe Wellness labeler code 83369

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.

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 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 9 words ▾

Stop use and ask a doctor if rash occurs

⏱️ Dosage and Administration 18 words ▾

Directions: After changing diaper allow the area to dry. then apply diaper rash cream liberally to affected areas.

⚠️ Warnings 18 words ▾

Warning: For external use only. When using this product keep out of eyes. Rinse with water to remove

🧪 Active Ingredient 8 words ▾

Active ingredients: Zinc Oxide 15% Purpose Skin protectant

🧪 Inactive Ingredients 76 words ▾

Water, Caprylic/Capric Triglyceride, Glycerin. C13-15 Alkane, Ethylhexyl Olivate, Propanediol, Polyglyceryl-3 Polyricinoleate, Bis-Octyldodecylhexyl Dimer Dilinoleate/Propanediol Copolymer, Cocoglycerides, Meadowfoam Estolide, Disteardimonium Hectorite, Jojoba Esters, Hydrogenated Castor Oil, Lactococcus Ferment Lysate, Rhus Verniciflua Peel Wax, Squalane, 1,2-Hexanediol, Butyrospermum Parkii (Shea) Butter, Caprylyl Glycol, Pyrus Malus (Apple) Fruit Extract, Sodium Chloride, Linoleic Acid, Betaine, Sucrose, Hydroxyacetophenone, Phospholipids, Phytosterols, Sodium Citrate, Hydrolyzed Rhodophyceae Extract, Bisabolol, Panthenol, Sodium Dehydroacetate, Stearyl Glycyrrhetinate, Tocopherol, Tetrasodium Glutamate Diacetate, Linolenic Acid, Avena Sativa (Oat) Kernel Extract.

🎯 Purpose 4 words ▾

Uses: Helps prevent irritation

📄 Keep Out of Reach of Children 21 words ▾

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

📄 Package Label / Principal Display Panel 13 words ▾

Diaper Rash Cream alleviate + soothe Net Wt oz 85g Daper Rash Cream

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

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 Diaper Rash Cream (this brand).

Top reported reactions

Macular Degeneration460
Pyrexia306
Nausea290
Pain282
Malaise261
Weight Decreased236
Therapeutic Product Effect Incomplete214

Age at onset

Neonate5
Infant8
Child28
Adolescent5
Adult110
Elderly192

Reporter sex

1,943 reports
Male · 37%
Female · 63%
Unknown · 0%
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 272 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.

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) ✓ 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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Smalls Brand LLC DBA Roe Wellness. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Smalls Brand LLC DBA Roe Wellness 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.
← 83369-0001-01 · Smalls 83369-0003-01 · Smalls →
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.