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In the Clear Acne Serum Salicylic Acid .5 g/100mL Liquid — NDC 69366-0414-31 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

In the Clear Acne Serum Salicylic Acid .5 g/100mL Liquid — NDC 69366-414-31 (Billing 69366-0414-31)

by The Honest Company, Inc · 1 BOTTLE, DROPPER in 1 CARTON / 30 mL in 1 BOTTLE, DROPPER

This is a package of In the Clear Acne Serum Salicylic Acid .5 g/100mL Liquid from The Honest Company, Inc, marketed since May 2022 and currently FDA-listed. It is this product's only package size.

NDC 69366-0414-31
🏷️ FDA NDC (as labeled) 69366-414-31 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 69366-414-31 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
69366 labeler · 414 product · 31 package
Package marketed since
May 1, 2022
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0810022917640
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69366-414-31
Product NDC 69366-414
11-digit billing NDC 69366041431
RxCUI 199308
UNII O414PZ4LPZ
UPC 0810022917640
Application # M006
SPL Set ID dc9e0545-43af-3d27-e053-2a95a90a5249
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-05-01
Route TOPICAL
Dosage form LIQUID
Substance SALICYLIC ACID
Quick answers
  • RxCUI (RxNorm): 199308
Why two NDCs? The FDA registers this code as 69366-414-31 — 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 → 69366-0414-31. 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 Salicylic acid and derivatives class.

Drug family (ATC) Salicylic acid and derivatives, Other antifungals for topical use, Antiinflammatory agents, non-steroids
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.

Clinical

📖 What it is MedlinePlus · NLM

Topical salicylic acid is used to help clear and prevent pimples and skin blemishes in people who have acne. Topical salicylic acid is also used to treat skin conditions that involve scaling or overgrowth of skin cells such as psoriasis (a skin disease in which red, scaly patches form on some areas of the body), ichthyoses (inborn conditions that cause skin dryness and scaling), dandruff, corns, calluses, and warts on the hands or feet. Topical salicylic acid should not be used to treat genital warts, warts on the face, warts with hair growing from them, warts in the nose or mouth, moles, or b...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It is used in a facial routine for acne-prone and oil-prone skin. The routine includes a cleanser, serum, toner and emulsion. Salicylic acid helps loosen and shed dead skin cells.
  • Use the cleanser morning and evening, and the serum in the morning after cleansing. Use the toner in the evening on dry skin, and the emulsion at night after cleansing. Avoid your...
  • Mild stinging, burning, itching, dryness and extra peeling can happen. If dryness or peeling bothers you, try using the serum or toner every other day. If it gets excessive, stop a...
  • It is best not to. Using another topical acne medication at the same time makes irritation and dryness more likely. If you get irritated, use only one at a time.
📖 Read our full Salicylic Acid Topical guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 mLPer 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
69366-0414-31 You're viewing this Main listing 1 BOTTLE, DROPPER in 1 CARTON / 30 mL in 1 BOTTLE, DROPPER 2022-05-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cetaphil Gentle Clear Triple-Action Acne Serum 5 mg/mL 00299-4135-00 Galderma 1 tube — — FDA listed —
Oxy Total Care Vitamin C Serum 5 mg/mL 10742-1315-01 The 1 vial — — FDA listed —
Up and Up Deep Clean Toner 5 mg/mL 11673-0936-11 TARGET 236.5 ml — — FDA listed —
Salicylic Acid 5 mg/mL 36800-0875-34 Topco 237 ml — — FDA listed —
Even Better Clinical Acne Solutions 5 mg/mL 49527-0114-01 CLINIQUE 1 bottle — — FDA listed —
ACNE solutions liquid MAKEUP SALICYLIC ACID ACNE TREATMENT 5 mg/mL 49527-0751-01 CLINIQUE 1 bottle — — Discontinued —
La Roche Posay Laboratoire Dermatologique Effaclar Clarifying 5 mg/mL 49967-0024-01 L'Oreal 200 ml — — FDA listed —
SkinCeuticals Silymarin CF Acne Treatment 5 mg/mL 49967-0068-01 L'Oreal 1 bottle — — FDA listed —
La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M Multi Target Acne Treatment 5 mg/mL 49967-0926-01 L'Oreal 1 tube — — FDA listed —
Salicylic Acid 5 mg/mL 55301-0875-34 Your 237 ml — — Discontinued —
Nutricentials Here You Glow Exfoliating Toner 5 mg/mL 62839-1339-01 NSE 150 ml — — FDA listed —
Clear Smart Clear Complexion Toner .5 g/100mL 68828-0289-01 Distribuidora 200 ml — — FDA listed —
In the Clear Acne Serum .5 g/100mLthis 69366-0414-31 The 1 bottle — — FDA listed —
La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M MultiTarget Acne Treatment 5 mg/mL 69625-0058-01 COSMETIQUE 15 tubes — — FDA listed —
SkinCeuticals Silymarin CF Acne Treatment Antioxidant 5 mg/mL 69625-0069-01 Cosmetique 1 bottle — — FDA listed —
La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M Multi Target Acne Treatment 5 mg/mL 69625-0926-01 COSMETIQUE 1 tube — — FDA listed —
Neutrogena Skin Clearing Blemish Concealer - Deep 20 5 mg/g 69968-0338-01 Kenvue 1 vial — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup - Classic Ivory 10 5 mg/mL 69968-0853-01 Kenvue 30 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup - Natural Ivory 20 5 mg/mL 69968-0854-01 Kenvue 30 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup - Buff 30 5 mg/mL 69968-0855-01 Kenvue 30 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup - Nude 40 5 mg/mL 69968-0856-01 Kenvue 30 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup - Soft Beige 50 5 mg/mL 69968-0857-01 Kenvue 30 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup - Natural Beige 60 5 mg/mL 69968-0858-01 Kenvue 30 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup - Fresh Beige 70 5 mg/mL 69968-0859-01 Kenvue 30 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup- Medium Beige 80 5 mg/mL 69968-0860-01 Kenvue 30 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup - Honey 85 5 mg/mL 69968-0861-01 Kenvue 30 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup - Warm Beige 90 5 mg/mL 69968-0862-01 Kenvue 30 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup- Natural Tan 100 5 mg/mL 69968-0863-01 Kenvue 30 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup - Caramel 105 5 mg/mL 69968-0864-01 Kenvue 30 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup - Cocoa 115 5 mg/mL 69968-0865-01 Kenvue 30 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup - Chestnut 135 5 mg/mL 69968-0866-01 Kenvue 30 ml — — FDA listed —
Clearsynergy .25 g/50mL 71617-0100-10 SRL 1 bottle — — FDA listed —
FHF Crisp Start .5 g/100g 72788-0151-03 Summer 1 tube — — FDA listed —
Dr. C. Tuna Acne Pore Purifying Toner 5 mg/mL 74690-0009-01 Farmasi 1 bottle — — FDA listed —
La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M MultiTarget Acne Treatment 5 mg/mL 82046-0058-01 L'Oreal 15 tubes — — FDA listed —
Ogee Clearganics Targeted Blemish Treatment .5 g/100mL 84261-0154-01 Ogee 10 ml — — FDA listed —
So Totally Clean Deep Pore Cleanser .5 g/100mL 70626-0104-21 ASPIRE 200 ml — — FDA listed —
Caring Mill Acne Clearing Cleanser .5 g/100mL 81522-0100-01 FSA 250 ml — — FDA listed —
Clear Smart Clarifying Cleansing Foam .5 g/100mL 68828-0244-01 Distribuidora 125 ml — — FDA listed —
Stridex Sensitive .5 g/100mL 10157-1007-01 Blistex 1 jar — — FDA listed —
Clarifying Cleanser .5 g/100mL 70381-0128-02 Murad, 1 tube — — 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

🏛️
2022
On the market since
May 2022
📍
2026
Currently FDA-listed
4 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.

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.

🧪 Avoiding an ingredient? See Salicylic Acid Topical inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 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 344S277G0Z
    Allantoin is a naturally derived compound that helps soften and soothe skin. In medicines, it works as a skin-conditioning agent and may help support wound healing and reduce irritation in topical formulations.
  • UNII F2VW3D43YT
    Azelaic acid is a naturally occurring compound that acts as a preservative and antimicrobial agent in medications. It helps prevent bacterial and fungal growth, extending the product's shelf life and stability.
  • 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 58B69Q84JO
    A plant-derived emulsifier made from olive oil and fatty alcohols. It helps blend oil and water ingredients together and stabilizes the product's texture in creams, lotions, and similar formulations.
  • UNII 5ZA2S6B08X
    Cetyl palmitate is a waxy substance made from natural fats. It works as a binder and thickener to help hold the medicine together and control how it dissolves in your body.
  • UNII 4828G836N6
    A plant-derived oil mixture from coconut that acts as an emollient and solvent. It helps dissolve or carry active ingredients and improves how the medicine spreads or absorbs in topical formulations.
  • 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 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 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 97AN39ICTC
    Sebacic acid is a waxy, fatty acid derived from plants or petroleum. It's used in medicines as a binder to hold ingredients together and as a film-former to create protective coatings on tablets and capsules.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 77K6Z421KU
    Sorbitan monopalmitate is an emulsifier made from sorbitol, a natural sugar alcohol, combined with palmitic acid. It helps mix oil and water ingredients together in medications and keeps them evenly blended throughout the product's shelf life.
  • UNII MDL271E3GR
    Sorbitan olivate is an emulsifier derived from sorbitol and olive oil. It helps blend water and oil ingredients together to maintain consistent texture and appearance throughout the medicine.
  • UNII YA22H34H9Q
    A chelating agent derived from sodium and organic compounds. It binds to metal ions in the formulation to improve stability and prevent unwanted chemical reactions that could degrade 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.
  • 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.
  • UNII C32PQ86DH4
    Zinc PCA is a zinc salt of pyroglutamic acid, a naturally occurring amino acid derivative. It's used in medications as a skin-conditioning agent and to help maintain product stability and texture in topical formulations.

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

The official label also statesInactive ingredients Water (Aqua/Eau), Propanediol, Niacinamide, Azelaic Acid, Coco-Caprylate, Zinc PCA, Allantoin, Sorbitan Olivate, Sorbitan Palmitate, Cetyl Palmitate, Cetearyl Olivate, Sebacic Acid, Xanthan Gum, Hydroxyacetophernone, Trisodium Ethylenedlamine Disuccinate, 1,2-Hexanediol, Caprylyl Glycol, Sodium Hydroxide.

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

LabelerThe Honest Company, Inc
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code69366
First marketedMay 2022
Product typeHuman Otc Drug
Portfolio5 products on file

More NDCs from The Honest Company, Inc labeler code 69366

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 📄 When Using This Product 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 7 words ▾

Use • For the treatment of acne.

⏱️ Dosage and Administration 73 words ▾

Directions • Clean the skin thoroughly before applying this product. • Cover the entire affected area with a thin layer one to three times daily. • Because excessive drying of the skin may occur, start with one applicaiton daily, then gradually increase to two or three times daily if needed or as direted by a doctor. • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

⚠️ Warnings 74 words ▾

Warnings For external use only. When using this product • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time • avoid contact with eyes. If contact occurs, rinse thoroughly with water. Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 5 words ▾

Active ingredient Salicylic Acid 0.5%

🧪 Inactive Ingredients 33 words ▾

Inactive ingredients Water (Aqua/Eau), Propanediol, Niacinamide, Azelaic Acid, Coco-Caprylate, Zinc PCA, Allantoin, Sorbitan Olivate, Sorbitan Palmitate, Cetyl Palmitate, Cetearyl Olivate, Sebacic Acid, Xanthan Gum, Hydroxyacetophernone, Trisodium Ethylenedlamine Disuccinate, 1,2-Hexanediol, Caprylyl Glycol, Sodium Hydroxide.

🎯 Purpose 3 words ▾

Purpose Acne treatment

📄 When Using This Product 49 words ▾

When using this product • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time • avoid contact with eyes. If contact occurs, rinse thoroughly with water.

📄 Keep Out of Reach of Children 20 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 45 words ▾

HONEST ® IN THE CLEAR ACNE SERUM ALL CLEAR Wintergreen Derived Salicylic Acid + Niacinamide + Zinc PCA 1.0 fl. oz. / 30 mL 888-862-8818 ©2022 Dist. by The Honest Company, Inc. Los Angeles, CA 90094 Made in USA from US and imported materials label

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

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

Medicare Part D (outpatient prescription) spending for Salicylic Acid (matched by generic name) — the program that covers self-administered drugs. 2 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Salicylic Acid. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$11.2K
Claims incl. refills
43
Beneficiaries
35
Spend / beneficiary
$319.01
Spend / claim
$259.66
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for In the Clear Acne Serum (this brand).

Top reported reactions

Vomiting216
Pruritus205
Weight Decreased188
Condition Aggravated184
Urticaria184
Weight Increased183
Hypertension181

Age at onset

Neonate7
Infant1
Child8
Adolescent5
Adult170
Elderly94

Reporter sex

1,852 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization622
Life-threatening174
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 252 93
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 The Honest Company, Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
The Honest Company, 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.
← 69366-0413-30 · The 69366-0503-20 · The →
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.