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Sunsolve MD Calm and Revitalize Zinc Oxide 132 mg/mL Lotion

by Sunsolve MD Inc · 1 BOTTLE, PUMP in 1 CARTON (84878-654-02) / 48 mL in 1 BOTTLE, PUMP (84878-654-01)
NDC 84878-0654-02
🏷️ FDA NDC (as labeled) 84878-654-02 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

⚠️
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

FDA NDC (as labeled) 84878-654-02
Product NDC 84878-654
11-digit billing NDC 84878065402
UNII SOI2LOH54Z
UPC 5061023120040
Application # M020
SPL Set ID 26f3f534-a305-3530-e063-6394a90a75e1
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-11-08
Route TOPICAL
Dosage form LOTION
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 84878-654-02 — 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 → 84878-0654-02. 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

LabelerSunsolve MD Inc
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code84878
First marketedNov 2024
Product typeHuman Otc Drug
Portfolio12 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?

Sunsolve MD Calm and Revitalize is a topical lotion containing zinc oxide, an inorganic mineral commonly used in over-the-counter skincare products. Zinc oxide is typically included in formulations for its role as a physical barrier agent and for general skin conditioning purposes. This product is marketed as an OTC monograph drug, meaning it follows established FDA guidelines for its category rather than undergoing individual product review.

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.

🧪 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
Indie Lee Daily Primer 132 mg/mL 78870-0245-02 America 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St12.5 Ramla Bay) 132 mg/mL 81110-0054-02 Ilia, 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St4 Formosa) 132 mg/mL 81110-0753-02 Ilia, 1 bottle — — FDA listed —
Golden Ray Sunscreen (Deep Tinted) 132 mg/mL 82184-1350-02 A-Frame 1 bottle — — Discontinued —
Daybird Tinted Skincare (SHADE 2) 132 mg/mL 82417-1063-02 Resette, 1 bottle — — FDA listed —
Ciele Bronze and Protect 132 mg/mL 83103-2255-02 Ciele 1 bottle — — FDA listed —
DRMTLGY Lip Silk - Bold 132 mg/mL 83286-0140-02 DRMTLGY 1 bottle — — FDA listed —
Alleyoop Sun Serum Lip Oil 132 mg/mL 84830-2107-02 NewAlley 1 bottle — — Discontinued —
Sunsolve MD Volumize and Condition Lip 132 mg/mL 84878-0107-02 Sunsolve 1 bottle — — FDA listed —
Sunsolve MD Mineral Shade Bronzite 004 132 mg/mL 84878-0404-02 Sunsolve 1 bottle — — FDA listed —
Sunsolve MD Mineral Shade Garnet 005 132 mg/mL 84878-0405-02 Sunsolve 1 bottle — — FDA listed —
Daily Essential Lip Oil Scarlet Bloom 132 mg/mL 84891-1842-01 Solarium 10 ml — — FDA listed —
Yon-Ka 50 Mineral Fluid 132 mg/mL 51191-2667-02 Laboratoire 1 tube — — FDA listed —
PUR 4-in-1 Skin Tint LG3 132 mg/mL 67345-0051-00 PUR 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St7 Diaz) 132 mg/mL 81110-0755-02 Ilia, 1 bottle — — FDA listed —
Bloomeffects Tulip Dew 132 mg/mL 82548-2193-04 Bloomeffects 1 bottle — — FDA listed —
Bloomeffects Tulip Dew Bronze 132 mg/mL 82548-2768-02 Bloomeffects 1 bottle — — FDA listed —
Melan RX 132 mg/mL 82635-0403-01 Melan 45 ml — — FDA listed —
Inde Wild 132 mg/mL 83054-1502-02 Inde 1 bottle — — FDA listed —
DRMTLGY Lip Silk - Soft 132 mg/mL 83286-0139-02 DRMTLGY 1 bottle — — FDA listed —
Blume Sunburst Sunscreen 132 mg/mL 83656-2106-02 Blume 1 bottle — — FDA listed —
Daily Essential Lip Oil Blushing Nude 132 mg/mL 84891-2107-01 Solarium 10 ml — — FDA listed —
Skin Metal Stealth 132 mg/mL 87098-0236-02 Skin 1 bottle — — FDA listed —
Knesko Skin The Sunscreen 132 mg/mL 87407-0236-02 Knesko, 1 bottle — — FDA listed —
PUR 4-in-1 Skin Tint DG6 132 mg/mL 67345-0057-00 PUR 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St9.5 Baikal) 132 mg/mL 81110-0052-02 Ilia, 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St17.5 Perissa) 132 mg/mL 81110-0059-02 Ilia, 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St19 Lovina) 132 mg/mL 81110-0060-02 Ilia, 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St6 Ora) 132 mg/mL 81110-0691-02 Ilia, 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St1 Rendezvous) 132 mg/mL 81110-0750-02 Ilia, 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St9 Paloma) 132 mg/mL 81110-0757-02 Ilia, 1 bottle — — FDA listed —
Golden Rays Sunscreen (Light Tinted) 132 mg/mL 82184-1351-02 A-Frame 1 bottle — — Discontinued —
Daybird Tinted Skincare (SHADE 1) 132 mg/mL 82417-1062-02 Resette, 1 bottle — — FDA listed —
Hanalei Face Moisturizing 132 mg/mL 82915-2133-02 Hanalei 1 tube — — FDA listed —
Balmere Mineral Sunscreen Moisturizer Primer 132 mg/mL 83241-1039-02 Balmere 1 bottle — — FDA listed —
Iris and Romeo Weekend Skin 132 mg/mL 83247-1321-02 Iris 1 tube — — FDA listed —
Iris and Romeo Weekend Skin Warm Glow 132 mg/mL 83247-1838-02 Iris 1 tube — — FDA listed —
Alleyoop Sun Serum Lip Oil - Daylight 132 mg/mL 84830-7210-02 NewAlley 1 bottle — — FDA listed —
Sunsolve MD Correct and Fade 132 mg/mL 84878-0200-02 Sunsolve 1 bottle — — FDA listed —
Solarium Daily Essentials Luminizing Glow Drops 132 mg/mL 84891-2191-01 Solarium 30 ml — — FDA listed —
Oiana Mineral Sunscreen Drops 132 mg/mL 87342-2368-02 Oiana 1 bottle — — FDA listed —
PUR 4-in-1 Skin Tint TN7 132 mg/mL 67345-0055-00 PUR 1 bottle — — FDA listed —
Riversol Daily Glow Mineral Tinted 132 mg/mL 72019-2035-02 Riversol 1 bottle — — FDA listed —
Volition Prismatic Luminizing Shield 132 mg/mL 72577-0624-02 Volition 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St10 Porto Ferro) 132 mg/mL 81110-0758-02 Ilia, 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St12 Kokkini) 132 mg/mL 81110-0760-02 Ilia, 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St16 Pavones) 132 mg/mL 81110-0764-02 Ilia, 1 bottle — — FDA listed —
KINLO Golden Rays Sunscreen 132 mg/mL 82184-4480-02 A-Frame 1 bottle — — Discontinued —
Daybird Tinted Skincare (SHADE 3) 132 mg/mL 82417-1064-02 Resette, 1 bottle — — FDA listed —
Ciele Tint and Protect 132 mg/mL 83103-1819-02 Ciele 1 bottle — — FDA listed —
Duette Tinted 132 mg/mL 84123-2034-02 Skin 1 bottle — — FDA listed —
Daily Essential Face Moisturizer 132 mg/mL 84891-2185-01 Solarium 60 ml — — FDA listed —
Sonni SunDay Serum 132 mg/mL 85260-0282-02 Sonni 1 bottle — — FDA listed —
Peachy Tinted Facial Sunscreen 132 mg/mL 85600-2034-02 Peachy 1 bottle — — FDA listed —
Peachy Mineral Facial Sunscreen 132 mg/mL 85600-2368-02 Peachy 1 bottle — — FDA listed —
Odacite Nourishing Lip Serum - Bubble Gum 132 mg/mL 82088-0871-02 Odacite 1 bottle — — FDA listed —
SOL Science The Fifty 132 mg/mL 83282-0139-02 Beauty 1 bottle — — FDA listed —
DRMTLGY Lip Silk 132 mg/mL 83286-0213-02 DRMTLGY 1 bottle — — Discontinued —
Riversol Tinted Lip Oil - Poppy 132 mg/mL 63931-8421-02 Solesence, 1 tube — — FDA listed —
PUR 4-in-1 Skin Tint DP3 132 mg/mL 67345-0056-00 PUR 1 bottle — — FDA listed —
Naked Sundays BeautyScreen Peptide Foundation Tint 132 mg/mL 81104-0664-02 Naked 1 tube — — FDA listed —
Ilia Super Serum Skin Tint (St0.5 Skye) 132 mg/mL 81110-0049-02 Ilia, 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St2.5 Sombrio) 132 mg/mL 81110-0050-02 Ilia, 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St11 Matira) 132 mg/mL 81110-0759-02 Ilia, 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St13 Kamari) 132 mg/mL 81110-0761-02 Ilia, 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St15 Porto Covo) 132 mg/mL 81110-0763-02 Ilia, 1 bottle — — FDA listed —
Bloomeffects Tulipscreen Hydrating Lip Oil Tulipy Pink 132 mg/mL 82548-2340-02 Bloomeffects 1 bottle — — FDA listed —
Covey Sun and Done Daily Moisturizing 132 mg/mL 83338-0087-02 Covey 1 tube — — FDA listed —
Vaihea Protect Clean SPF Drops 132 mg/mL 83395-0050-02 Vaihea 1 bottle — — FDA listed —
Organys Derma Made 132 mg/mL 83612-0330-01 Organys 45 ml — — Discontinued —
Organys Open Formula Sheer 132 mg/mL 83612-1391-01 Organys 45 ml — — FDA listed —
Green Envee Radiance Sheer 132 mg/mL 83678-2726-02 Green 1 bottle — — FDA listed —
Alleyoop Sunsational Broad Spectrum 132 mg/mL 84830-2431-02 NewAlley 1 tube — — Discontinued —
Sunsolve MD Firm and Replenish 132 mg/mL 84878-0199-02 Sunsolve 1 bottle — — FDA listed —
Sunsolve MD Calm and Revitalize 132 mg/mLthis 84878-0654-02 Sunsolve 1 bottle — — FDA listed —
Riversol Daily Glow Mineral Untinted 132 mg/mL 72019-2033-02 Riversol 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St6.5 Kai) 132 mg/mL 81110-0051-02 Ilia, 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St12.75 Papakolea) 132 mg/mL 81110-0055-02 Ilia, 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St13.5 Rialto) 132 mg/mL 81110-0056-02 Ilia, 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St16.5 Jardin) 132 mg/mL 81110-0058-02 Ilia, 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St5 Bom Bom) 132 mg/mL 81110-0754-02 Ilia, 1 bottle — — FDA listed —
Odacite Nourishing Lip Serum - True Nude 132 mg/mL 82088-0875-02 Odacite 1 bottle — — FDA listed —
Live Tinted Hueguard Skin Tint 132 mg/mL 82153-0192-02 Live 1 tube — — FDA listed —
Bloomeffects Tulipscreen Hydrating Lip Oil 132 mg/mL 82548-2341-02 Bloomeffects 1 bottle — — Discontinued —
Organys Derma Made Sheer 132 mg/mL 83612-1039-01 Organys 45 ml — — FDA listed —
Sunsolve MD Mineral Shade Quartz 001 132 mg/mL 84878-0401-02 Sunsolve 1 bottle — — FDA listed —
PUR 4-in-1 Skin Tint MN3 132 mg/mL 67345-0052-00 PUR 1 bottle — — FDA listed —
Odacite Flex Perfecting Mineral Drops Tinted Sunscreen 132 mg/mL 82088-0214-02 Odacite 1 bottle — — FDA listed —
Daybird Tinted Skincare (SHADE 4) 132 mg/mL 82417-1065-02 Resette, 1 bottle — — FDA listed —
Organys Derma Made 132 mg/mL 83612-0282-01 Organys 45 ml — — Discontinued —
Agent Natuer holi (sun) dewy tinted skin drops 132 mg/mL 83633-2063-02 Agent 1 bottle — — FDA listed —
Guise Tinted Drops 132 mg/mL 83827-1208-02 Donis 1 bottle — — FDA listed —
Duette Untinted 132 mg/mL 84123-2033-02 Skin 1 bottle — — FDA listed —
Depology Essential Mineral UV Care 132 mg/mL 84133-1039-02 Depology 1 tube — — FDA listed —
Morning Person Daily Repair Protect Moisturizer 132 mg/mL 84846-1039-02 Morning 1 tube — — FDA listed —
Sunsolve MD Mineral Shade Amber 002 132 mg/mL 84878-0402-02 Sunsolve 1 bottle — — FDA listed —
Daily Essential Lip Oil Dusty Rose 132 mg/mL 84891-2181-01 Solarium 10 ml — — FDA listed —
Riversol Tinted Lip Oil - Poppy 132 mg/mL 72019-1842-02 Riversol 1 tube — — FDA listed —
Ilia Super Serum Skin Tint (St11.5 Morgat) 132 mg/mL 81110-0053-02 Ilia, 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St14.5 Honopu) 132 mg/mL 81110-0057-02 Ilia, 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St3 Balos) 132 mg/mL 81110-0752-02 Ilia, 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St8 Shela) 132 mg/mL 81110-0756-02 Ilia, 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St14 Dominica) 132 mg/mL 81110-0762-02 Ilia, 1 bottle — — FDA listed —
Odacite Nourishing Lip Serum - Jazzy Berry 132 mg/mL 82088-0876-02 Odacite 1 bottle — — FDA listed —
Daybird 4-in-1 Skin Tint Serum 132 mg/mL 82417-1210-02 Resette, 1 bottle — — FDA listed —
Green Envee Sun Shield Serum 132 mg/mL 83678-2049-02 Green 1 bottle — — Discontinued —
Sunsolve MD Mineral Shade Agate 003 132 mg/mL 84878-0403-02 Sunsolve 1 bottle — — FDA listed —
PUR 4-in-1 Skin Tint MN4 132 mg/mL 67345-0053-00 PUR 1 bottle — — FDA listed —
PUR 4-in-1 Skin Tint TN2 132 mg/mL 67345-0054-00 PUR 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St2 Tulum) 132 mg/mL 81110-0751-02 Ilia, 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St17 Miho) 132 mg/mL 81110-0765-02 Ilia, 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St18 Mali) 132 mg/mL 81110-0766-02 Ilia, 1 bottle — — FDA listed —
DMK Ultrascreen Mineral Sunscreen 132 mg/mL 81537-0282-02 Danne 1 bottle — — FDA listed —
Odacite Mineral Drops Sheer Sunscreen 132 mg/mL 82088-0285-02 Odacite 1 bottle — — FDA listed —
KINLO Golden Rays Sunscreen (Medium Tinted) 132 mg/mL 82184-1173-02 A-Frame 1 bottle — — Discontinued —
Bloomeffects Tulipscreen Hydrating Lip Oil Barely 132 mg/mL 82548-1234-02 Bloomeffects 1 bottle — — FDA listed —
Bloomeffects Tulipscreen Hydrating Lip Oil Fruit Punch 132 mg/mL 82548-2350-02 Bloomeffects 1 bottle — — FDA listed —
Bloomeffects Tulipscreen Hydrating Lip Oil Mauve Moment 132 mg/mL 82548-2601-02 Bloomeffects 1 bottle — — FDA listed —
Aspen Islanders Sheer Mineral Sport 132 mg/mL 83382-1005-02 Aspen 1 tube — — FDA listed —
Organys Derma Made 132 mg/mL 83612-0403-01 Organys 45 ml — — FDA listed —
Sunsolve MD Mineral Shade Onyx 006 132 mg/mL 84878-0406-02 Sunsolve 1 bottle — — FDA listed —
Sunsolve MD Balance and Clear 132 mg/mL 84878-0997-02 Sunsolve 1 bottle — — FDA listed —
Sunsolve MD Detox and Shield 132 mg/mL 84878-0998-02 Sunsolve 1 bottle — — FDA listed —
Skin Metal Green Stealth 132 mg/mL 87098-0270-02 Skin 1 bottle — — FDA listed —
BEAUTY SHIELD BROAD SPECTRUM SUNSCREEN (Napoleon Perdis) 132 mg/mL 51386-0291-02 Napoleon 1 tube — — FDA listed —
PUR 4-in-1 Skin Tint LN2 132 mg/mL 67345-0050-00 PUR 1 bottle — — FDA listed —
Omnilux Mineral Facial Sunscreen 132 mg/mL 83866-1762-02 The 1 bottle — — 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

🏛️
2024
On the market since
Nov 2024
📍
2026
Currently FDA-listed
2 years 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.

🔬 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 Sunsolve MD Calm and Revitalize (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

1,941 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization988
Life-threatening116
Disabling32
Reports over time (by year) — tap or hover for the count & year
2021 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
84878-0654-02 You're viewing this 1 BOTTLE, PUMP in 1 CARTON (84878-654-02) / 48 mL in 1 BOTTLE, PUMP (84878-654-01) 2024-11-08 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 — Not published for this NDC No photo available yet for this listing.
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 84878-654-02, 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: 84878-0654-02, written without dashes as 84878065402. 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 84878-0654-02, the first segment (84878) is the labeler code FDA assigned to Sunsolve MD Inc; the middle segment (0654) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) 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 Sunsolve MD Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Sunsolve MD Inc 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 8 words ▾

Sunsolve MD Calm and Revitalize Indications & usage

⏱️ Dosage and Administration 8 words ▾

Sunsolve MD Calm and Revitalize Dosage and Administration

⚠️ Warnings 7 words ▾

Sunsolve MD Calm and Revitalize Warning Label

🧪 Active Ingredient 7 words ▾

Sunsolve MD Calm and Revitalize Active Ingredients

🧪 Inactive Ingredients 7 words ▾

Sunsolve MD Calm and Revitalize Inactive ingredients

🎯 Purpose 6 words ▾

Sunsolve MD Calm and Revitalize purpose

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 84878-0406-02 · Sunsolve 84878-0823-02 · Sunsolve →
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.