Home › NDC Lookup › Ingredients › Hydrocortisone › 00924-5634-04
Hydrocortisone 1% Anti-ItchCream 10 mg/g Cream, 25 packets — NDC 00924-5634-04 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Hydrocortisone 1% Anti-ItchCream 10 mg/g Cream, 25 packets — NDC 0924-5634-04 (Billing 00924-5634-04)

by Acme United Corporation · 25 PACKET in 1 CARTON / .9 g in 1 PACKET

This is a package of 25 packets of Hydrocortisone 1% Anti-ItchCream 10 mg/g Cream from Acme United Corporation, marketed since Jun 2026 and currently FDA-listed.

NDC 00924-5634-04
🏷️ FDA NDC (as labeled) 0924-5634-04 billing pads the labeler segment with a zero
This package
Contains25 packets Pack sizes3 compare ↓
Product page 00924-5634-00 Also comes in: 9 g 0924-5634-00 12 packets 0924-5634-02
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 0924-5634-04 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0924 labeler · 5634 product · 04 package
Package marketed since
Jun 30, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0092265074865
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0924-5634-04
Product NDC 0924-5634
11-digit billing NDC 00924563404
RxCUI 106258
UNII WI4X0X7BPJ
UPC 0092265074865
Application # M017
SPL Set ID 5425fc2b-4f25-3e64-e063-6394a90aff49
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 2026-06-30
Route TOPICAL
Dosage form CREAM
Substance HYDROCORTISONE
Quick answers
  • RxCUI (RxNorm): 106258
Why two NDCs? The FDA registers this code as 0924-5634-04 — a 4-4-2 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 labeler segment → 00924-5634-04. 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

📗 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.
Try another pack size: 9 g 12 packets
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
00924-5634-00 0924-5634-00 Main listing .9 g in 1 PACKET 2026-06-30 — Active
00924-5634-02 0924-5634-02 12 PACKET in 1 CARTON / .9 g in 1 PACKET 2026-06-30 — Active
00924-5634-04 You're viewing this 25 PACKET in 1 CARTON / .9 g in 1 PACKET 2026-06-30 — Active

Pack size FAQ

What quantity is in this package?
This package contains 25 packets — 25 packet in 1 carton / .9 g in 1 packet.
How does this package differ from NDC 00924-5634-00?
Both are Hydrocortisone 1% Anti-ItchCream 10 mg/g Cream — the drug itself is identical. This page's package is the 25 packets one, while NDC 00924-5634-00 is the 9 g package.
What NDC number is used to bill for this package of Hydrocortisone 1% Anti-ItchCream 10 mg/g 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
hydrocortisone 10 mg/g 00168-0015-16 E. 453.6 g $0.109 AT Availability likely —
Hydrocortisone 10 mg/g 00472-0321-26 Actavis 1 tube $0.112 AT Availability likely —
Hydrocortisone 10 mg/g 00168-0020-16 E. 453.6 g $0.138 AT Availability likely —
Hydrocortisone 10 mg/g 62559-0430-01 ANI 1 tube $0.600 AT Availability likely —
Proctocort 10 mg/g 65649-0501-30 Salix 1 tube — AT Discontinued —
Dr. Sheffield Hydrocortisone Anti itch 10 mg/g 11527-0052-51 Sheffield 1 tube — — FDA listed —
CeraVe Developed with Dermatologists Anti Itch 10 mg/g 49967-0108-01 L'Oreal 1 tube — — FDA listed —
SKIN A COOL Hydrocortisone Anti-Itch 10 mg/g 70288-0173-00 Ana-Cool, 56.7 g — — FDA listed —
Ana Cool Rapid Soothing Cooling Formula 10 mg/g 70288-0714-01 Ana-Cool, 1 bottle — — FDA listed —
Thera plus Anti-itch with aloe Hydrocortisone 10 mg/g 80684-0038-01 Fourstar 1 tube — — FDA listed —
Hydrocortisone 10 mg/g 73141-0622-28 A2A 1 tube — — FDA listed —
Thera Plus Maximum Strength Hydrocortisone 10 mg/g 80684-0145-00 Fourstar 42.5 g — — FDA listed —
Cortizone 10 Cooling Relief 10 mg/g 41167-0036-00 Chattem, 1 tube — — FDA listed —
Hydrocortisone 10 mg/g 47682-0397-35 Unifirst 144 packets — — FDA listed —
Quadrydern 10 mg/g 59428-0403-57 Productos 1 tube — — FDA listed —
Viaderma Calm Anti-Itch 10 mg/g 71262-0014-15 ViaDerma 1 bottle — — FDA listed —
Hydrocortisone 10 mg/g 00924-1133-00 Acme 9 g — — FDA listed —
Alacort 10 mg/g 00316-0126-01 Crown 1 tube — AT FDA listed —
Hydrocortisone 10 mg/g 00316-0186-01 Crown 1 tube — AT FDA listed —
Winco Maximum Strength Hydrocortisone 10 mg/g 67091-0197-28 WINCO 1 tube — — FDA listed —
CVS Health Hydrocortisone Anti Itch 10 mg/g 69842-0155-10 CVS 24 packets — — Discontinued —
Aveeno 1% Hydrocortisone Anti-Itch Cream 10 mg/g 69968-0888-01 Kenvue 1 tube — — FDA listed —
Thera Plus Hydrocortisone Maximum Strength 10 mg/g 80684-0151-00 FOURSTAR 42.5 g — — FDA listed —
Quality Choice 10 mg/g 83324-0297-01 Chain 1 tube — — FDA listed —
Cortizone 10 10 mg/g 41167-0039-00 Chattem, 1 tube — — Discontinued —
Hydrocortisone 10 mg/g 51316-0227-00 CVS 1 tube — — FDA listed —
Crane Safety Hydrocortisone 10 mg/g 73408-0933-73 Crane 25 packets — — FDA listed —
Cortizone 10 Intensive Healing for Eczema 10 mg/g 41167-0331-00 Chattem, 1 tube — — FDA listed —
Family Wellness Max Strength 1 Hydrocortisone Cream 10 mg/g 55319-0982-00 Family 1 tube — — FDA listed —
Hydrocortisone 10 mg/g 63629-1951-01 Bryant 1 tube — AT FDA listed —
Barmicil Plus 10 mg/g 69729-0103-11 OPMX 28 g — — FDA listed —
Hydrocortisone 10 mg/g 72162-1763-02 Bryant 1 tube — AT FDA listed —
THERAPLEX AIM Anti-Itch Moisturizing 10 mg/g 82280-0478-02 THERAPLEX, 56.7 g — — FDA listed —
Hydrocortisone 10 mg/g 82942-1003-01 J&A 9 g — — FDA listed —
Itch and Rash Cream 10 mg/g 84269-4506-01 Wildman 25 packets — — FDA listed —
Hydrocortisone 10 mg/g 85766-0166-10 Sportpharm 10 pouches — — FDA listed —
Hydrocortisone 10 mg/g 43473-0049-01 Nantong 9 g — — FDA listed —
SurviveX Hydrocortisone Cream 10 mg/g 43473-0313-01 Nantong 9 g — — FDA listed —
DermaCort Anti-itch 10 mg/g 54473-0117-28 Melaleuca, 28 g — — FDA listed —
Hydrocortisone 10 mg/g 00363-9981-02 Walgreens 1 tube — — FDA listed —
Cortizone 10 Intensive Healing 10 mg/g 41167-0035-00 Chattem, 1 tube — — FDA listed —
Thompson Hydrocortisone 1% 10 mg/g 73408-0937-73 Thompson 25 packets — — FDA listed —
Preparation H Soothing Relief Anti-Itch 10 mg/g 00573-0552-11 Haleon 1 tube — — FDA listed —
Equate Hydrocortisone 10 mg/g 79903-0092-01 WalMart 1 tube — — FDA listed —
Hydrocortisone 10 mg/g 47682-0211-12 Unifirst 10 pouches — — FDA listed —
Hydrocortisone anti-itch plus 10 mg/g 49035-0732-02 Wal-Mart 1 tube — — FDA listed —
Hydrocortisone 10 mg/g 51316-0230-00 CVS 1 tube — — FDA listed —
Hydrocortisone 10 mg/g 72189-0209-28 DIRECT 28.4 g — AT FDA listed —
First Aid Only Hydrocortisone 1% Anti-Itch 10 mg/g 00924-5633-00 Acme 9 g — — FDA listed —
ProCure Hydrocortisone Cream Plus 10 mg/g 29784-0142-28 Rooftop 1 tube — — FDA listed —
Anti-itch 10 mg/g 53329-0091-01 Medline 1 tube — — FDA listed —
Hydrocortisone 10 mg/g 61010-5800-02 Safetec 144 pouches — — FDA listed —
Aveeno Hydrocortisone ANTI-ITCH 10 mg/g 69968-0511-01 Kenvue 1 tube — — FDA listed —
Thera Plus Maximum Strength Hydrocortisone 10 mg/g 80684-0197-00 Fourstar 6 packets — — FDA listed —
Hydrocortisone 10 mg/g 84387-0005-01 ALLIED 28.4 g — — FDA listed —
WinCo Foods Hydrocortisone Cream Intensive Healing 10 mg/g 67091-0419-28 WINCO 1 tube — — FDA listed —
TheraCare Hydrocortisone Cream 10 mg/g 71101-0220-01 Veridian 1 tube — — FDA listed —
Preparation H Hydrocortisone 10 mg/g 00573-2830-10 Haleon 1 tube — — FDA listed —
Thera Plus Eczema Hydrocortisone Anti Itch 10 mg/g 80684-0146-00 Fourstar 28 g — — FDA listed —
FifthPulse Hydrocortisone 10 mg/g 87525-0003-01 WeCare 1 tube — — FDA listed —
Hydrocortisone 10 mg/g 47682-0933-73 Unifirst 25 pouches — — FDA listed —
Hydrocortisone 1% Anti-ItchCream 10 mg/gthis 00924-5634-04 Acme 25 packets — — FDA listed —
Drs. Hydrocortisone Aloe Vera 10 mg/g 80489-0088-01 OL 1 tube — — FDA listed —
Quadriderm NF 10 mg/g 69729-0828-02 OPMX 1 tube — — FDA listed —
Diprospan 10 mg/g 69729-0794-02 OPMX 1 tube — — FDA listed —
Barmicil Plus 10 mg/g 69729-0830-01 OPMX 1 tube — — FDA listed —
Aerosoothe 10 mg/g 55305-0136-02 Aero 25 packets — — FDA listed —
Barmicil Plus 10 mg/g 69729-0834-01 OPMX 1 tube — — FDA listed —
Terramed Just Think Comfort Hydrocortisone 1% Cream 10 mg/g 83004-0051-01 Rida 1 jar — — 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

🏛️
2026
On the market since
Jun 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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.

🧪 Avoiding an ingredient? See Hydrocortisone 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 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 FCZ5MH785I
    A waxy substance made from glycerin and stearic acid. It works as an emulsifier to help mix oil and water ingredients together, and as a thickener to give the medicine its proper texture and consistency.
  • UNII 15O9QS218W
    A chemical preservative that prevents mold, bacteria, and yeast from growing in liquid medicines and personal care products. It keeps the product safe and effective throughout its shelf life.
  • 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 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • UNII 9O3K93S3TK
    Trolamine is an alkaline compound used as a pH buffer and emulsifier in medicines. It helps neutralize acids, stabilize formulations, and enable mixing of oil and water-based ingredients.
  • 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 B6E5W8RQJ4
    White petrolatum is a purified mineral oil product used as a lubricant and skin protectant in medications. It helps pills slide through manufacturing equipment and can soften or protect the skin when applied topically.

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

The official label also statescetostearyl alcohol, glyceryl monostearate SE, kathon CG, propylene glycol, purified water, stearic acid, trolamine, white petrolatum

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

LabelerAcme United Corporation
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code00924
First marketedJun 2026
Product typeHuman Otc Drug
Portfolio59 products on file

More NDCs from Acme United Corporation labeler code 00924

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 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 27 words ▾

Uses temporarily relieves itching associated with minor skin irritations and rashes other uses of this product should only be under the advice and supervision of a doctor

⏱️ Dosage and Administration 31 words ▾

Directions adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.

⚠️ Warnings 88 words ▾

Warnings For external use only Avoid Contact with the eyes Do not use If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, Stop use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor .Do not use for the treatment of diaper rash. Consult a doctor. Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

🧪 Active Ingredient 6 words ▾

Active ingredient Hydrocortisone 1% Purpose (Anti-itch)

🧪 Inactive Ingredients 18 words ▾

Inactive ingredients cetostearyl alcohol, glyceryl monostearate SE, kathon CG, propylene glycol, purified water, stearic acid, trolamine, white petrolatum

🎯 Purpose 2 words ▾

Purpose (Anti-itch)

📄 Do Not Use 58 words ▾

Do not use If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, Stop use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor .Do not use for the treatment of diaper rash. Consult a doctor.

📄 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. (1-800-222-1222)

📄 Questions or Comments 3 words ▾

Questions? Call 1-800.835.2263

📄 Package Label / Principal Display Panel 4 words ▾

Package Labeling: carton 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 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.

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 Acme United Corporation. 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 2 other package presentations of this same product, including 9 g (00924-5634-00), 12 packets (00924-5634-02). 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?
Acme United 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.
← 00924-5633-00 · Acme 00924-5702-00 · Acme →
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.