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Gerigentle Hydrocortisone 10 mg/g Cream, 28.3 g — NDC 69771-0192-13 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Gerigentle Hydrocortisone 10 mg/g Cream, 28.3 g — NDC 69771-192-13 (Billing 69771-0192-13)

by GERI-GENTLE CORPORATION · 28.3 g in 1 TUBE

This is a package of 28.3 g of Gerigentle Hydrocortisone 10 mg/g Cream from GERI-GENTLE CORPORATION, marketed since Nov 2023 and currently FDA-listed. It is this product's only package size.

NDC 69771-0192-13
🏷️ FDA NDC (as labeled) 69771-192-13 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 69771-192-13 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
69771 labeler · 192 product · 13 package
Package marketed since
Nov 23, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0648289162608
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69771-192-13
Product NDC 69771-192
11-digit billing NDC 69771019213
RxCUI 1043690
UNII 3X7931PO74
UPC 0648289162608
Application # M017
SPL Set ID 0adfa2f0-9758-5c54-e063-6294a90a461f
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-11-23
Route TOPICAL
Dosage form CREAM
Substance HYDROCORTISONE ACETATE
Quick answers
  • RxCUI (RxNorm): 1043690
Why two NDCs? The FDA registers this code as 69771-192-13 — 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 → 69771-0192-13. 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 Corticosteroid class.

Pharmacologic class Corticosteroid
Drug family (ATC) Corticosteroids, moderately potent (group II), Corticosteroids, potent (group III), Corticosteroids for local oral treatment
How it works Corticosteroid Hormone Receptor Agonists
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

Hydrocortisone topical is used to treat redness, swelling, itching, and discomfort of various skin conditions. Hydrocortisone is in a class of medications called corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It depends on the product. Tablets and oral granules are used for adrenal insufficiency, among other conditions. Injections are used for severe allergic states and skin diseases. R...
  • Don't stop it suddenly if you take it for adrenal insufficiency. Stopping abruptly can cause adrenal crisis, which can be fatal. Talk to your prescriber before making any changes.
  • Common ones are fluid retention, higher blood pressure, changes in blood sugar, mood changes, bigger appetite and weight gain. Call your doctor for signs of infection, vision chang...
  • Grapefruit juice and some antifungals and antibiotics can raise hydrocortisone levels. Some seizure medicines and rifampicin can lower them. Tell me about any diabetes medicines, w...
📖 Read our full Hydrocortisone guide →
8
Nutrient depletion considerations

Hydrocortisone may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Hydrocortisone nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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
69771-0192-13 You're viewing this Main listing 28.3 g in 1 TUBE 2023-11-23 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Walgreens Eczema Relief 10 mg/g 00363-0357-02 Walgreen 1 tube — — FDA listed —
Hydrocortisone Acetate 10 mg/g 47832-0205-05 Bentlin 576 packets — — FDA listed —
Hydrocortisone 10 mg/g 50332-0042-01 HART 10 packets — — FDA listed —
Hydrocortisone 10 mg/g 50332-0092-01 HART 10 packets — — FDA listed —
MedPride 10 mg/g 52410-3050-02 Shield 9 g — — FDA listed —
Hydrocortisone 1 g/100g 59898-0800-01 Water-Jel 1728 packets — — FDA listed —
Gerigentle 10 mg/gthis 69771-0192-13 GERI-GENTLE 28.3 g — — FDA listed —
American Safety and First Aid 10 mg/g 71927-0015-02 Orazen 25 pouches — — FDA listed —
astonea 10 mg/g 77338-0305-02 ASTONEA 9 g — — FDA listed —
Equate Hydrocortione 10 mg/g 79903-0211-01 Walmart 1 tube — — FDA listed —
ElixirCortiRelief 1 g/100g 84546-0005-01 ELIXIR 1 tube — — FDA listed —
Thompson Hydrocortisone 1% 10 mg/g 73408-0981-73 Thompson 25 packets — — FDA listed —
Green Guard Hydrocortisone 1% 10 mg/g 47682-0398-73 Unifirst 25 packets — — 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

🏛️
2023
On the market since
Nov 2023
📍
2026
Currently FDA-listed
3 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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 I835H2IHHX
    A waxy substance derived from plant oils, used as an emulsifier and solubilizer to help mix oil and water ingredients together and keep them blended throughout the product's shelf life.
  • UNII 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII 36W53O7109
    Chlorocresol is a phenolic antimicrobial chemical used as a preservative in liquid medicines and injectable solutions. It prevents bacterial and fungal growth to maintain product safety and shelf-life.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • UNII 4T6H12BN9U
    Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 4VON5FNS3C
    Sodium metabisulfite is a preservative derived from sulfur compounds. It prevents microbial growth and oxidation in medicines, helping extend shelf life and maintain product stability.
  • 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.

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

The official label also statescetostearyl alcohol, chlorocresol, ceteth-20, edetate disodium, liquid paraffin, propylene glycol, purified water, sodium metabisulphite, white soft paraffin

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

LabelerGERI-GENTLE CORPORATION
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code69771
First marketedNov 2023
Product typeHuman Otc Drug
Portfolio22 products on file

More NDCs from GERI-GENTLE CORPORATION labeler code 69771

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 51 words ▾

Uses ■ for temporary relief of minor skin irritations, itching and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, and for external genital, feminine and anal itching. Other uses of this product should be only under the advice and supervision of a doctor

⏱️ Dosage and Administration 97 words ▾

Directions ■ adults and children over 2 years of age ■ apply evenly to affected area no more than 3 to 4 times daily ■ children under 2 years of age■ do not use, consult a doctor ■ Adults ■ when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly ■ gently dry, patting or blotting with bathroom tissue or soft cloth before applying ■ apply externally to the area up to 6 times a daily or after a bowel movement ■ after application discard pad ■ do not flush in toilet

⚠️ Warnings 5 words ▾

Warnings For external use only

🧪 Active Ingredient 7 words ▾

Active Ingredient Hydrocortisone Acetate USP (1% w/w)

🧪 Inactive Ingredients 19 words ▾

Inactive Ingredients cetostearyl alcohol, chlorocresol, ceteth-20, edetate disodium, liquid paraffin, propylene glycol, purified water, sodium metabisulphite, white soft paraffin

🎯 Purpose 2 words ▾

Purpose Anti-itch

📄 Do Not Use 23 words ▾

Do not use ■ in the eyes ■ for diaper rash ■ if you have vaginal discharge ■ more than the recommended dosage

📄 Ask a Doctor Before Use If 13 words ▾

Ask a doctor before use ■ if you are pregnant or breast feeding

📄 Stop Use and Ask a Doctor If 30 words ▾

Stop use and ask a doctor if ■ the condition worsens, or if symptoms persist for more than 7 days or clear up and occur again wihin a few days

📄 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 8 words ▾

Package Label Drug Facts and Principal Display Panel

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 Hydrocortisone (matched by generic name) — the program that covers self-administered drugs. 17 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 Hydrocortisone. CMS lists 11 products for this generic; we show the highest-spend one. 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
$19.92M
Claims incl. refills
699.9K
Beneficiaries
529.9K
Spend / beneficiary
$37.60
Spend / claim
$28.47
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 Gerigentle (this brand).

Top reported reactions

Fatigue5,919
Condition Aggravated5,454
Nausea4,998
Rash4,908
Diarrhoea4,449
Headache4,425
Pain4,422

Age at onset

Neonate332
Infant314
Child1,040
Adolescent683
Adult7,947
Elderly3,424

Reporter sex

66,647 reports

Serious outcomes

Hospitalization28,426
Death9,794
Life-threatening8,648
Disabling5,601
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 6,429 2,806
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 GERI-GENTLE CORPORATION. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
GERI-GENTLE CORPORATION 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.
← 69771-0165-03 · GERI-GENTLE 69777-0180-02 · BLUEZONWIDE →
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.