Home › NDC Lookup › Ingredients › Zinc Oxide › 82812-0958-00
Miami Beach Bum SPF 30 Bodyguard Face Body Mineral Sunscreen ZINC OXIDE 150 mg/mL Cream, 100 mL — NDC 82812-0958-00 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Miami Beach Bum SPF 30 Bodyguard Face Body Mineral Sunscreen ZINC OXIDE 150 mg/mL Cream, 100 mL — NDC 82812-958-00 (Billing 82812-0958-00)

by Miami Beach Bum · 100 mL in 1 TUBE

This is a package of 100 mL of Miami Beach Bum SPF 30 Bodyguard Face Body Mineral Sunscreen ZINC OXIDE 150 mg/mL Cream from Miami Beach Bum, marketed since Apr 2026 and currently FDA-listed. It is this product's only package size.

NDC 82812-0958-00
🏷️ FDA NDC (as labeled) 82812-958-00 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 82812-958-00 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
82812 labeler · 958 product · 00 package
Package marketed since
Apr 16, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 8281295800 8
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) 82812-958-00
Product NDC 82812-958
11-digit billing NDC 82812095800
UNII SOI2LOH54Z
Application # M020
SPL Set ID 3b778530-9af0-48eb-bd91-d9ac99f2983f
Established class (EPC) Copper Absorption Inhibitor
Physiologic effect Decreased Copper Ion Absorption
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-04-16
Route TOPICAL
Dosage form CREAM
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 82812-958-00 — 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 → 82812-0958-00. 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?

Miami Beach Bum SPF 30 Bodyguard is a mineral sunscreen cream applied to the face and body. It contains zinc oxide, a physical sunscreen agent that works by reflecting and scattering ultraviolet rays away from the skin. This product is an over-the-counter monograph sunscreen, meaning it is marketed under the FDA's established rules for sunscreen drugs rather than as an individually approved application.

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
82812-0958-00 You're viewing this Main listing 100 mL in 1 TUBE 2026-04-16 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Proven Personalized Day Moisturizer With SPF 50 150 mg/mL 73572-0004-30 Proven 30 ml — — FDA listed —
MIAMI BEACH BUM Save Face SPF-30 Sunscreen 150 mg/mL 82812-0336-00 MIAMI 100 ml — — FDA listed —
MIAMI BEACH BUM Blocked SPF-30 Sunscreen 150 mg/mL 82812-0337-00 MIAMI 180 ml — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Tinted Moisturizer 150 mg/mL 90086-0012-01 Clean 40 ml — — FDA listed —
SEAWEED BATH CO Everyday Mineral SPF 40 150 mg/mL 81159-0259-00 The 100 ml — — FDA listed —
Miami Beach Bum SPF 30 Bodyguard Face Body Mineral Sunscreen 150 mg/mLthis 82812-0958-00 Miami 100 ml — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Four 150 mg/mL 90086-0017-01 Clean 1 tube — — FDA listed —
Sqween Paint-On Sun Protection for Independent Kids Mineral Sunscreen SPF 30 150 mg/mL 83005-0002-01 Sqween 118 ml — — FDA listed —
ETADERM Tattoo Sunscreen Broad Spectrum SPF-30 150 mg/mL 84180-0472-00 NUEPHASE 118 ml — — FDA listed —
Oathology Inzincable Lip Balm SPF 35 150 mg/mL 85562-0694-00 SKINOATH 1 tube — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Three and Half 150 mg/mL 90086-0016-01 Clean 1 tube — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Five 150 mg/mL 90086-0019-01 Clean 1 tube — — FDA listed —
Sun Bum Daily Mineral Sunscreen Moisturizer Broad Spectrum SPF 30 150 mg/mL 69039-0761-02 Sun 1 bottle — — FDA listed —
Saie Sunvisor Broad Spectrum SPF 35 Sheer Moisturizer 150 mg/mL 90086-0011-01 Clean 1 tube — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Four and Half 150 mg/mL 90086-0018-01 Clean 1 tube — — FDA listed —
Calendula Essential Hydrating Broad Spectrum SPF 30 Sunscreen 150 mg/mL 64657-0007-02 Naturopathica 1 tube — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Three 150 mg/mL 90086-0015-01 Clean 1 tube — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Nine 150 mg/mL 90086-0024-01 Clean 1 tube — — FDA listed —
Sqween 100% Mineral Sunscreen Broad Spectrum SPF 30 Water Resistant 150 mg/mL 83005-0001-01 SQWEEN 60 ml — — FDA listed —
Good Weather Skin The One Daily Sun Warm Glow SPF 30 150 mg/mL 85090-0002-01 Good 1 bottle — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Nine and Half 150 mg/mL 90086-0025-01 Clean 1 tube — — FDA listed —
Lion Pose Ghost-Buster Broad Spectrum Spf 42 Sunscreen 150 mg/mL 83605-0001-01 Lion 2 ml — — Discontinued —
Cancer Council Mineral Fluid SPF50 150 mg/mL 84258-0006-01 Vitality 1 tube — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade One 150 mg/mL 90086-0013-01 Clean 1 tube — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer ShadeTwo 150 mg/mL 90086-0014-01 Clean 1 tube — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Eight 150 mg/mL 90086-0023-01 Clean 1 tube — — FDA listed —
Duke Cannon Supply Co. Daily Defense Face Mineral Sunscreen Broad Spectrum SPF 32 150 mg/mL 71782-0201-03 DUKE 1 tube — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Ten 150 mg/mL 90086-0026-01 Clean 1 tube — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Five and Half 150 mg/mL 90086-0020-01 Clean 1 tube — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Six 150 mg/mL 90086-0021-01 Clean 1 tube — — FDA listed —
Lion Pose Unghosted Tinted Mineral Spf 42 Uva Uvb Sunscreen 150 mg/mL 83605-0002-01 Lion 1 bottle — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Seven 150 mg/mL 90086-0022-01 Clean 1 tube — — FDA listed —
Sqween Mineral Sunscreen Broad Spectrum SPF 30 Light Green 150 mg/mL 83005-0005-01 Sqween 60 ml — — FDA listed —
Sqween Mineral Sunscreen Broad Spectrum SPF 30 Blue 150 mg/mL 83005-0003-01 Sqween 60 ml — — FDA listed —
Sqween Mineral Sunscreen Broad Spectrum SPF 30 Blue 150 mg/mL 58419-0011-00 Atlantis 60 ml — — FDA listed —
Sqween Mineral Sunscreen Broad Spectrum SPF 30 Pink 150 mg/mL 83005-0006-01 Sqween 60 ml — — FDA listed —
Sqween Mineral Sunscreen Broad Spectrum SPF 30 Gold 150 mg/mL 83005-0004-01 Sqween 60 ml — — FDA listed —
Sqween Mineral Sunscreen Broad Spectrum SPF 30 Rose Gold 150 mg/mL 83005-0007-01 Sqween 60 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

🏛️
2026
On the market since
Apr 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 ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
  • UNII UOI4FT57BZ
    Broccoli is a vegetable extract used in medicines as a source of natural compounds and nutrients. It may serve as a filler, colorant, or nutritional additive in formulations.
  • UNII P0M7O4Y7YD
    A plant extract from calendula flowers, traditionally used in formulations. It typically serves as a botanical ingredient that may provide color, fragrance, or skin-conditioning properties to topical products.
  • 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 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 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII 0N8672707O
    A starch derived from corn kernels. It acts as a binder to hold tablet ingredients together, a filler to give the tablet bulk, and a disintegrant to help the tablet break apart in your stomach.
  • UNII Z17H97EA6Y
    A plant-derived mild cleanser made from natural sugars and oils. It acts as an emulsifier and surfactant to help mix water and oil-based ingredients together in the medicine.
  • 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 Y98611C087
    Glyceryl laurate is an emulsifier made by combining glycerin and lauric acid. It helps mix oil and water-based ingredients together in the medicine and may improve how the product feels or spreads.
  • 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 W2ZU1RY8B0
    A plant extract from green tea leaves. It's used as an antioxidant ingredient to help preserve the medicine and maintain its stability during storage.
  • UNII BKJ0J3D1BP
    A plant-derived ingredient from sunflower flowers, used as a natural colorant and flavoring agent in medicines. It may help provide color or mild taste to the product.
  • UNII T4V6TWG28D
    A plant-derived thickening agent made from cellulose. It increases viscosity and helps form a gel or paste consistency in medications, and may serve as a binder or coating material in various formulations.
  • UNII A8289P68Y2
    Isododecane is a lightweight liquid hydrocarbon used as a solvent and spreadability agent in topical formulations. It helps dissolve active ingredients and makes the product easier to apply and absorb into the skin.
  • UNII 724GKU717M
    Jojoba oil is a natural liquid wax extracted from jojoba plant seeds. It's used in medicines as an emollient and lubricant to soften and smooth the product, and sometimes as a carrier or penetration enhancer.
  • 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 25X51I8RD4
    Niacinamide is a form of vitamin B3, a water-soluble nutrient. In medicines, it may be added as a nutritional supplement or to support skin health, though its primary role here is as an active ingredient rather than a traditional inactive filler.
  • 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 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 AZQ08K38Z1
    A synthetic oily liquid derived from salicylic acid. It works as an emollient and penetration enhancer in topical formulations, helping active ingredients absorb into skin while conditioning and softening the application area.
  • 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.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also statesAlgae Extract, Aloe Barbadensis Leaf (Aloe Vera Gel), Aqua (Deionized Water), Brassica Oleracea Italica (Broccoli) Extract, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetyl Alcohol, Citric Acid, Decyl Glucoside, Glycerin, Glyceryl Laurate, Glyceryl Stearate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil, Hydroxyethylcellulose, Isododecane, Niacinamide, Polyhydroxystearic Acid, Simmondsia Chinensis (Jojoba) Oil, Squalane, Tridecyl Salicylate, Trimethylsiloxysilicate, Xanthan Gum, Zeamea (Corn) Propanediol.

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

LabelerMiami Beach Bum
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code82812
First marketedApr 2026
Product typeHuman Otc Drug
Portfolio5 products on file

More NDCs from Miami Beach Bum labeler code 82812

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 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 49 words ▾

Uses • Helps prevent sunburn. • higher SPF gives more sunburn protection. • eretains SPF after 40 minutes of swimming or sweating. • If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.

⏱️ Dosage and Administration 97 words ▾

Directions Apply liberally 15 minutes before sun exposure and as needed. Children under 6 months of age: ask a doctor. Reapply: after 40 minutes of swimming or sweating immediately after towel drying at least every 2 hours Sun Protection Measures.

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10 a.m. - 2 p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses.

⚠️ Warnings 72 words ▾

Warnings For external use only not intended for ingestion. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash or irritation develops and lasts. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, ask a health professional before use.

🧪 Active Ingredient 7 words ▾

Active Ingredients Zinc Oxide 15.00% Purpose Sunscreen

🧪 Inactive Ingredients 69 words ▾

Inactive Ingredients Algae Extract, Aloe Barbadensis Leaf (Aloe Vera Gel), Aqua (Deionized Water), Brassica Oleracea Italica (Broccoli) Extract, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetyl Alcohol, Citric Acid, Decyl Glucoside, Glycerin, Glyceryl Laurate, Glyceryl Stearate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil, Hydroxyethylcellulose, Isododecane, Niacinamide, Polyhydroxystearic Acid, Simmondsia Chinensis (Jojoba) Oil, Squalane, Tridecyl Salicylate, Trimethylsiloxysilicate, Xanthan Gum, Zeamea (Corn) Propanediol.

🎯 Purpose 2 words ▾

Purpose Sunscreen

📄 Do Not Use 8 words ▾

Do not use on damaged or broken skin.

📄 When Using This Product 13 words ▾

When using this product keep out of eyes. Rinse with water to remove.

📄 Stop Use and Ask a Doctor If 13 words ▾

Stop use and ask a doctor if rash or irritation develops and lasts.

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breast-feeding, ask a health professional before use.

📄 Keep Out of Reach of Children 19 words ▾

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

📄 Package Label / Principal Display Panel 3 words ▾

Package Labeling: Label.jpg

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

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 Miami Beach Bum. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Miami Beach Bum 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.
← 82812-0448-00 · MIAMI 82816-0002-01 · Enited, →
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.