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Calm and Heal Melting Balm Allantoin .5 g/100g Cream — NDC 69366-0505-23 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Calm and Heal Melting Balm Allantoin .5 g/100g Cream — NDC 69366-505-23 (Billing 69366-0505-23)

by The Honest Company, Inc. · 1 JAR in 1 CARTON / 50 g in 1 JAR

This is a package of Calm and Heal Melting Balm Allantoin .5 g/100g Cream from The Honest Company, Inc., marketed since Sep 2020 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 69366-0505-23
🏷️ FDA NDC (as labeled) 69366-505-23 billing pads the product segment with a zero
This package
Contains50 g in 1 jar Pack sizes2 compare ↓
Main listing for product 69366-505 · Also comes in: 15 g 69366-505-28
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 69366-505-23 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
69366 labeler · 505 product · 23 package
Package marketed since
Sep 29, 2020
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6936650523 0
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69366-505-23
Product NDC 69366-505
11-digit billing NDC 69366050523
UNII 344S277G0Z
Application # M016
SPL Set ID b08a1bd6-986d-9520-e053-2995a90a865e
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-09-29
Route TOPICAL
Dosage form CREAM
Substance ALLANTOIN
Why two NDCs? The FDA registers this code as 69366-505-23 — 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 → 69366-0505-23. 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?

Calm and Heal Melting Balm is a topical cream containing allantoin, marketed as an over-the-counter monograph drug. Allantoin is commonly included in skin-care products and is typically used to help soothe and soften skin. This product is applied directly to the skin surface and is formulated as a cream that melts upon contact.

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 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.
Try another pack size: 15 g
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
69366-0505-23 You're viewing this Main listing 1 JAR in 1 CARTON / 50 g in 1 JAR 2020-09-29 — Active
69366-0505-28 69366-505-28 1 JAR in 1 CARTON / 15 g in 1 JAR Sample 2021-09-01 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 jar in 1 carton / 50 g in 1 jar.
What NDC number is used to bill for this package of Calm and Heal Melting Balm Allantoin .5 g/100g Cream?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Calm and Heal Melting Balm .5 g/100gthis 69366-0505-23 The 1 jar — — FDA listed —
Drs. pharmacy Scar Cream .5 g/100g 80489-0333-01 OL 1 tube — — FDA listed —
Advanced Bed Sore Wound Healing .5 g/100g 87512-0001-01 Yantai 15 g — — FDA listed —
TerrasilMed ONC .5 g/100g 24909-0029-50 Aidance 50 g — — FDA listed —
terrasil Infection Protection Wound Care .5 g/100g 24909-0030-14 Aidance 14 g — — FDA listed —
terrasil Skin Repair .5 g/100g 24909-0032-14 Aidance 14 g — — FDA listed —
Advanced Silicone Scar .5 g/100g 87512-0006-01 Yantai 20 g — — FDA listed —
Nasal Dryness Relief Gel .5 g/100g 10738-0051-10 Genuine 1 tube — — FDA listed —
911 .5 g/100g 61328-0120-11 Skinfix, 50 g — — FDA listed —
Dermachange Scar .5 g/100g 83520-0297-00 Private 1 tube — — FDA listed —
terrasil Scar Recovery .5 g/100g 24909-0043-28 Aidance 28 g — — FDA listed —
ARC Skin Protectant .5 g/100g 69148-0001-00 Anjon 118.6 g — — Discontinued —
Advanced Formula Scar Defense Cream .5 g/100g 87512-0002-01 Yantai 20 g — — FDA listed —
Teevodar .5 g/100g 69435-1301-01 PEER 1 tube — — FDA listed —
Healing Head to Toe .5 g/100g 69366-0508-29 The 141 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

🏛️
2020
On the market since
Sep 2020
📍
2026
Currently FDA-listed
6 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.

💡 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 QN83US2B0N
    Ascorbyl palmitate is a fat-soluble form of vitamin C used as an antioxidant in medicines. It prevents oils and fats in the product from breaking down and becoming less stable over time.
  • UNII 0C9AC7D6XU
    A plant-derived fat from shea nut kernels that remains after soap-making. It acts as a moisturizer, emollient, and texture enhancer in topical formulations, helping soften skin and improve product spreadability.
  • 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 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 YSE9PPT4TH
    Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
  • 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 Q613OCQ44Y
    Isostearyl alcohol is a fatty alcohol derived from plant or petroleum sources. It acts as an emollient and thickener in formulations, helping to soften the product and improve texture and stability.
  • UNII F7540880P0
    A synthetic oily compound made from plant-based stearic acid. It works as an emulsifier and thickener to help blend oil and water ingredients together and give the medicine a smooth, stable texture.
  • UNII 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • 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 DE08037SAB
    Magnesium sulfate is a mineral salt that acts as an osmotic agent in medications. It draws water into the intestines to soften stool or is used as a filler and processing aid in some solid dosage forms.
  • UNII 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • 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 90PS6JV9GZ
    A plant-derived ingredient from the Ophiopogon japonicus root, used in traditional medicine formulations. It may serve as a natural filler or consistency agent in herbal preparations.
  • UNII M51422LRAM
    Polyglycerin-6 is a synthetic compound made from glycerin molecules linked together. In medicines, it acts as an emulsifier and humectant, helping mix oil and water-based ingredients and retain moisture in the formulation.
  • UNII 9229XJ4V12
    A synthetic emulsifier made from glycerin and fatty acids. It helps blend oil and water-based ingredients in formulations, keeping them mixed and preventing separation.
  • UNII YPM0ZOC2HR
    A synthetic emulsifier derived from glycerin and castor oil. It helps mix oil and water-based ingredients together in the formulation to create a uniform product and improve texture.
  • UNII YXH47AOU0F
    A synthetic fatty acid used as a thickener and stabilizer in medicines. It helps create the right texture and prevents separation of ingredients in liquid or semi-solid formulations.
  • 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 R60QEP13IC
    Rice bran is a natural powder made from the outer layer of rice grains. It's used in medicines as a filler and flow agent to add bulk and help the product mix and flow smoothly during manufacturing.
  • UNII WN66R7GL93
    A modified form of hyaluronic acid, a naturally occurring substance that holds water. Used as a thickener, lubricant, and moisture-retaining agent in formulations, especially in topical or injectable products.
  • UNII PL360EPO9J
    Soy sterol is a plant-derived fat extracted from soybeans. It's used as an emulsifier and stabilizer to help keep oil and water mixed together and maintain the medicine's texture and consistency.
  • UNII 3W1JG795YI
    Sunflower oil is a natural vegetable oil derived from sunflower seeds. It serves as a solvent, lubricant, and carrier in medicines, helping dissolve active ingredients and improve how the medication flows and absorbs in the body.
  • 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 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.

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

The official label also statesInactive ingredients Water (Aqua/Eau),Helianthus Annuus (Sunflower) Seed Oil,Caprylic/Capric Triglyceride,Oryza Sativa (Rice) Bran Wax,Polyhydroxystearic Acid, Polyglyceryl-6 Polyhydroxystearate, Polyglyceryl-6 Polyricinoleate, Magnesium Sulfate,Propanediol,Glycerin, Butyrospermum Parkii (Shea) Butter, Phytosterols,Phospholipids, Linoleic Acid, Hydrolyzed Sodium Hyaluronate, Sodium Acetylated Hyaluronate, Ophiopogon Japonicus Root Extract, Maltodextrin, Polyglycerin-6, Trisodium Ethylenediamine Disuccinate, Isostearyl Hydroxystearate, Hydroxyacetophenone, 1,2-Hexanediol, Caprylyl Glycol,Isostearyl Alcohol,Tocopherol, Ascorbyl Palmitate

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 applicationM016 (OTC MONOGRAPH DRUG)
Labeler code69366
First marketedSep 2020
Product typeHuman Otc Drug
Portfolio13 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 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 29 words ▾

Uses Temporarily protects minor: •cuts •scrapes •burns Helps prevent and helps relieve chapped or cracked skin Helps prevent and protect from the drying effects of wind and cold weather

⏱️ Dosage and Administration 26 words ▾

Directions Apply as needed. Warm up product in hands to transform the rich cream to a silky balm, then gently massage a thin layer onto skin.

⚠️ Warnings 57 words ▾

Warnings For external use only When using this product do not get into eyes. Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center immediately

🧪 Active Ingredient 4 words ▾

Active ingredient Allantoin 0.5%

🧪 Inactive Ingredients 51 words ▾

Inactive ingredients Water (Aqua/Eau),Helianthus Annuus (Sunflower) Seed Oil,Caprylic/Capric Triglyceride,Oryza Sativa (Rice) Bran Wax,Polyhydroxystearic Acid, Polyglyceryl-6 Polyhydroxystearate, Polyglyceryl-6 Polyricinoleate, Magnesium Sulfate,Propanediol,Glycerin, Butyrospermum Parkii (Shea) Butter, Phytosterols,Phospholipids, Linoleic Acid, Hydrolyzed Sodium Hyaluronate, Sodium Acetylated Hyaluronate, Ophiopogon Japonicus Root Extract, Maltodextrin, Polyglycerin-6, Trisodium Ethylenediamine Disuccinate, Isostearyl Hydroxystearate, Hydroxyacetophenone, 1,2-Hexanediol, Caprylyl Glycol,Isostearyl Alcohol,Tocopherol, Ascorbyl Palmitate

🎯 Purpose 3 words ▾

Purpose skin protectant

📄 When Using This Product 9 words ▾

When using this product do not get into eyes.

📄 Stop Use and Ask a Doctor If 25 words ▾

Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days

📄 Keep Out of Reach of Children 18 words ▾

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

📄 Package Label / Principal Display Panel 3 words ▾

label carton

label

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 The Honest Company, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 jar (69366-0505-28). Each has its own NDC and its own page — see the package list near the top of this page.
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.
← 69366-0504-19 · The 69366-0507-17 · 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.