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Baby Diaper Rash Cream Zinc oxide 25 g/100g Cream, 60 g — NDC 71630-549-60 (Billing 71630-0549-60)

by doTERRA International, LLC · 60 g in 1 TUBE

This is a package of 60 g of Baby Diaper Rash Cream Zinc oxide 25 g/100g Cream from doTERRA International, LLC, marketed since May 2018 and currently FDA-listed. It is this product's only package size.

NDC 71630-0549-60
🏷️ FDA NDC (as labeled) 71630-549-60 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 71630-549-60 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
71630 labeler · 549 product · 60 package
Package marketed since
May 9, 2018
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7163054960 4
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) 71630-549-60
Product NDC 71630-549
11-digit billing NDC 71630054960
RxCUI 1125471
UNII SOI2LOH54Z
Application # M020
SPL Set ID 641465a1-0daf-1bb9-e053-2a91aa0ab25d
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-05-09
Route TOPICAL
Dosage form CREAM
Substance ZINC OXIDE
Quick answers
  • RxCUI (RxNorm): 1125471
Why two NDCs? The FDA registers this code as 71630-549-60 — 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 → 71630-0549-60. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

🧪 What is this product?

This is an over-the-counter cream containing zinc oxide, a mineral ingredient commonly used in diaper rash products. Applied topically to the skin, zinc oxide typically functions as a barrier and protectant, helping to shield the diaper area from moisture and irritants. This product is marketed under FDA's established rules for over-the-counter diaper rash creams rather than as an individually reviewed drug 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
71630-0549-60 You're viewing this Main listing 60 g in 1 TUBE 2018-05-09 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Kinesys 25 g/100g 61481-0036-02 Wilc 60 g — — FDA listed —
Baby Diaper Rash Cream 25 g/100gthis 71630-0549-60 doTERRA 60 g — — FDA listed —
Babo Fragrance Free Diaper Cream 25 g/100g 79265-8566-03 Babo 85 g — — FDA listed —
Babo Botanicals Sensitive Baby Fragrance Free Diaper Rash 250 mg/g 79265-8580-01 Babo 170 g — — FDA listed —
Jardient TALLOW SUNSCREEN 25 g/100g 85646-0005-01 GLOWVERA 1 bottle — — Discontinued —
Bellas Friends Sunscreen Stick 25 g/100g 85950-0003-01 Panergytek 15 g — — FDA listed —
Sky and Sol Sunscreen SPF 50 25 g/100g 84632-0503-03 Delta 1 g — — FDA listed —
Hawaiian Natural Zinc Sunscreen SPF 50 25 g/100g 72096-0101-01 Kokua 89 g — — FDA listed —
All Good Mineral Sport Sunscreen Butter 25 g/100g 75786-0223-29 Elemental 29 g — — FDA listed —
All Good Mineral Sport Sunscreen Butter Stick SPF 50 25 g/100g 75786-0229-78 Elemental 78 g — — FDA listed —
Alba Botanica Sheer Mineral SPF50 25 g/100g 61995-3030-01 The 59 g — — FDA listed —
All Good kids mineral sunscreen butter stick SPF 50 25 g/100g 75786-0230-78 Elemental 78 g — — FDA listed —
Badger Adventure Sport Clear Mineral Sunscreen SPF 50 25 g/100g 62206-5023-03 W.S. 68 g — — FDA listed —
Sheer Guard Natural Mineral Sunscreen Broad Spectrum SPF 50 25 g/100g 70157-0028-02 Baxter 1 tube — — FDA listed —
All Good Tinted Mineral Sunscreen Butter SPF 50 25 g/100g 75786-0226-29 Elemental 29 g — — FDA listed —
Arnies Mineral Sunscreen - Broad Spectrum SPF 50 with Zinc Oxide 25 g/100g 87237-0001-01 Gimmie 88 g — — FDA listed —
Utu Hydrating Sun Balm Broad Spectrum SPF 50 25 g/100g 87952-0003-03 Utu 1 can — — 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

🏛️
2018
On the market since
May 2018
📍
2026
Currently FDA-listed
8 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 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 595AO13F11
    Carrot seed oil is a plant-based oil extracted from carrot seeds. It's used in medicines as a flavor and fragrance component, and may help distribute active ingredients evenly throughout the formulation.
  • UNII 9S60Q72309
    A plant-derived ingredient made from safflower seed components. It acts as an emulsifier and carrier to help distribute oils and active ingredients evenly throughout the medicine.
  • 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 ZBP1YXW0H8
    A fragrant oil extracted from lavender plants, used as a flavoring and scent agent in medicines to improve taste and aroma.
  • 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 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 VIF565UC2G
    Tea tree oil is an essential oil extracted from the leaves of the Australian tea tree plant. In medicines, it typically serves as a flavoring agent, fragrance, or antimicrobial component in topical formulations.
  • 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 2ZA36H0S2V
    Beeswax is a natural wax produced by honeybees. In medicines, it works as a coating agent and thickener to control how fast the drug dissolves and improve the product's texture and appearance.

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

The official label also statesInactive ingredients: Caprylic/Capric Triglyceride, Simmondsia chinensis (Jojoba) Seed Oil, Beeswax (Cera Alba), Butyrospermum parkii (Shea) Butter, Carthamus tinctorius (Safflower) Oleosomes, Water (Aqua), Caprylyl Glycol, Lavandula angustifolia (Lavender) Oil, Daucus carota sativa (Carrot) Seed Oil, Melaleuca alternifolia (Tea Tree) Leaf Oil

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

LabelerdoTERRA International, LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code71630
First marketedMay 2018
Product typeHuman Otc Drug
Portfolio10 products on file

More NDCs from doTERRA International, LLC labeler code 71630

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 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 21 words ▾

Uses • Helps treat and prevent diaper rash • Protects chafed skin due to diaper rash and helps seal out wetness

⏱️ Dosage and Administration 49 words ▾

Active ingredient Purpose Zinc Oxide 25%...........................Skin Protectant Directions • Change wet or soiled diapers promptly • Cleanse the diaper area and allow to dry • Apply cream liberally as often as necessary with each diaper change especially at bedtime or any time exposure to wet diapers may be prolonged

⚠️ Warnings 6 words ▾

For external use only. Drug Facts

🧪 Active Ingredient 5 words ▾

Zinc Oxide 25% Zinc Oxide

🧪 Inactive Ingredients 41 words ▾

Inactive ingredients: Caprylic/Capric Triglyceride, Simmondsia chinensis (Jojoba) Seed Oil, Beeswax (Cera Alba), Butyrospermum parkii (Shea) Butter, Carthamus tinctorius (Safflower) Oleosomes, Water (Aqua), Caprylyl Glycol, Lavandula angustifolia (Lavender) Oil, Daucus carota sativa (Carrot) Seed Oil, Melaleuca alternifolia (Tea Tree) Leaf Oil DFP

🎯 Purpose 4 words ▾

Skin protectant Drug Facts

📄 When Using This Product 9 words ▾

When using this product do not get into eyes

📄 Stop Use and Ask a Doctor If 30 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 DF Diaper Cream

📄 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.

📄 Other Information 20 words ▾

Other information • Store between 20º to 25ºC (68º to 77ºF) • Do not use if quality seal is broken

📄 Questions or Comments 3 words ▾

Questions? Call 1-800-411-8151

📄 Package Label / Principal Display Panel 24 words ▾

Principal Display Panel and Package Label doTERRA® baby Diaper Rash Cream Helps Treat, Soothe, and Prevent Diaper Rash Net wt. 2.1 oz/60 g PDP

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

Reported adverse events (FAERS)

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

Top reported reactions

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

Age at onset

Neonate5
Infant8
Child28
Adolescent5
Adult110
Elderly192

Reporter sex

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

Serious outcomes

Hospitalization988
Life-threatening116
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 270 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
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 doTERRA International, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
doTERRA International, LLC 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.
← 71630-0176-18 · doTERRA 71630-0966-50 · doTERRA →
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.