Icy Hot Pain Relieving Cream Menthol and Methyl Salicylate 10 g/100g; 30 g/100g Cream — NDC 41167-0088-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Icy Hot Pain Relieving Cream Menthol and Methyl Salicylate 10 g/100g; 30 g/100g Cream — NDC 41167-0088-1 (Billing 41167-0088-01)

by Chattem, Inc. · 1 TUBE in 1 CARTON / 85 g in 1 TUBE

This is a package of Icy Hot Pain Relieving Cream Menthol and Methyl Salicylate 10 g/100g; 30 g/100g Cream from Chattem, Inc., marketed since Jun 1991 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 41167-0088-01
🏷️ FDA NDC (as labeled) 41167-0088-1 billing pads the package segment with a zero
This package
Contains85 g in 1 tube Pack sizes2 compare ↓
Main listing for product 41167-0088 · Also comes in: 35.4 g 41167-0088-5
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

NDC database record

One package, one record: these facts belong to NDC 41167-0088-1 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
41167 labeler · 0088 product · 1 package
Package marketed since
Jun 1, 1991
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 4116700881 3
FDA record last changed
Oct 1, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 41167-0088-1
Product NDC 41167-0088
11-digit billing NDC 41167008801
NCPDP billing unit GM — per gram (weight)
UNII LAV5U5022Y, L7T10EIP3A
Application # M017
SPL Set ID 40c8c02f-fa5f-4e80-81a0-48271fa6f94b
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1991-06-01
Route TOPICAL
Dosage form CREAM
Substance MENTHOL; METHYL SALICYLATE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 006034
GCN 80609
HICL code 002583
Ingredient (HICL) Methyl Salicylate/Menthol
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L6
Therapeutic class — intermediate (HIC2) Irritants
HIC3 code L6A
Therapeutic class — specific (HIC3) Irritants/Counter-Irritants
AHFS code 28:08.04.24
AHFS class Salicylates
FDB label name ICY HOT CREAM
FDB brand name Icy Hot
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 006034
  • GCN: 80609
  • HICL (First Databank): 002583
  • AHFS class code: 28:08.04.24
  • RxCUI (RxNorm): 311500
Why two NDCs? The FDA registers this code as 41167-0088-1 — a 5-4-1 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 package segment → 41167-0088-01. 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

Label name ICY HOT CREAM Ingredient Methyl Salicylate/Menthol
📗 Our plain-language guide HelloPharmacist
  • It is used on the skin for short-term relief of minor muscle and joint aches. That includes arthritis, backache, strains, sprains and bruises. Some products, like Diclofenac Sodium...
  • Apply it only to clean, intact skin, and follow your product's directions on how often. Wash your hands after using creams or handling patches, and keep it away from your eyes. Don...
  • A short burning feeling, redness or mild irritation where you apply it is the most common. It usually fades in several days. Stop and call your doctor if you get severe burning, bl...
  • Be careful. Methyl salicylate is a salicylate, related to aspirin, and labels say to talk to a doctor first if you are prone to allergic reactions to aspirin or salicylates. Some l...
📖 Read our full Menthol / Methyl Salicylate guide →
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: 35.4 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
41167-0088-01 You're viewing this Main listing 1 TUBE in 1 CARTON / 85 g in 1 TUBE 1991-06-01 — Active
41167-0088-05 41167-0088-5 1 TUBE in 1 CARTON / 35.4 g in 1 TUBE 1991-06-01 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 tube in 1 carton / 85 g in 1 tube.
What NDC number is used to bill for this package of Icy Hot Pain Relieving Cream Menthol and Methyl Salicylate 10 g/100g; 30 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
Signature Care Cold and Hot 30 g/100g; 10 g/100g 21130-0861-36 Safeway 1 tube — — FDA listed —
Icy Hot Pain Relieving Cream 10 g/100g; 30 g/100gthis 41167-0088-01 Chattem, 1 tube — — FDA listed —
Meijer Extra Strength Cold And Hot TherapyPain Relieving Topical Analgesic 100 mg/g; 300 mg/g 41250-0378-01 Meijer 1 tube — — FDA listed —
Equate Cool and Heat 100 mg/g; 300 mg/g 49035-0470-01 Wal-Mart 1 tube — — FDA listed —
Family Wellness Hot and Cold Pain Relief 100 mg/g; 300 mg/g 55319-0824-35 FAMILY 1 tube — — FDA listed —
CVS Health Cold and Hot Pain Relieving Extra Strength 100 mg/g; 300 mg/g 59779-0791-01 CVS 1 tube — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
1991
On the market since
Jun 1991
📍
2026
Currently FDA-listed
35 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Menthol / Methyl Salicylate 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 LU49E6626Q
    A synthetic organic compound used as a pH buffer and neutralizing agent in medicines. It helps maintain the proper acidity level in liquid formulations to improve stability and comfort.
  • UNII 0A5MM307FC
    A synthetic polymer that absorbs water and forms a thick, gel-like substance. In medicines, it works as a thickener and stabilizer to improve texture and help ingredients stay mixed together in creams, gels, and lotions.
  • 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 D072FFP9GU
    Cetyl esters wax is a waxy substance made from natural or synthetic fatty acids. It's used as a binder, hardening agent, and coating material to give tablets and capsules their structure and texture.
  • UNII 8Q0Z18J1VL
    A surfactant derived from oleic acid, a naturally occurring fatty acid. It helps mix oil and water-based ingredients together in formulations, improving product stability and texture.
  • UNII CAL22UVI4M
    A synthetic emulsifier derived from sorbitol and fatty acids. It helps mix oil and water-based ingredients together and improves the texture and stability of the medicine.
  • 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 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.

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

The official label also statesceresin, cyclomethicone, hydrogenated castor oil, microcrystalline wax, paraffin, PEG-150 distearate, propylene glycol, stearic acid, stearyl alcohol (245-111) ICYHOT ® PAIN RELIEVING BALM Drug Facts paraffin, white petrolatum ICYHOT ® PAIN RELIEVING CREAM Drug Facts aminomethyl propanol, carbomer, cetearyl alcohol, cetyl esters, oleth-3 phosphate, polysorbate 60, stearic acid, water Replace cap after each use.

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

LabelerChattem, Inc.
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code41167
First marketedJun 1991
Product typeHuman Otc Drug
Portfolio157 products on file
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 49 words ▾

Uses temporarily relieves minor pain associated with: arthritis simple backache muscle strains sprains bruises cramps

Uses temporarily relieves minor pain associated with: arthritis simple backache muscle strains sprains bruises cramps

Uses temporarily relieves minor aches and pains of muscles and joints associated with: arthritis simple backache strains sprains bruises

⏱️ Dosage and Administration 149 words ▾

Directions adults and children over 12 years: apply a thin layer to affected area massage into painful area until thoroughly absorbed into skin repeat as necessary, but not more than 4 times daily children 12 years or younger: ask a doctor

Directions adults and children over 12 years: ■ apply a thin layer to affected area ■ massage into painful area until thoroughly absorbed into skin ■ repeat as necessary, but no more than 4 times daily ■ AFTER APPLYING, WASH HANDS WITH SOAP AND WATER children 12 years or younger: ask a doctor

Directions ■ adults and children 12 years of age and older: ■ apply a thin layer to affected area not more than 3 to 4 times daily ■ massage until thoroughly absorbed into skin ■ wash hands thoroughly with soap and water after each use ■ children under 12 years of age: ask a doctor

⚠️ Warnings ~3 min read ▾

Warnings For external use only SEE INSIDE LABEL FOR COMPLETE DRUG FACTS Allergy Alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use. When using this product ■ use only as directed. Read and follow all directions and warnings on this label. ■ avoid contact with eyes and mucous membranes ■ rare cases of serious burns have been reported with products of this type ■ do not apply to wounds or damaged, broken or irritated skin ■ do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use ■ a transient burning sensation may occur upon application but generally disappears in several days ■ if severe burning sensation occurs, discontinue use immediately ■ do not expose the area treated with product to heat or direct sunlight Stop use and ask a doctor if condition worsens redness is present irritation develops symptoms persist for more than 7 days or clear up and occur again within a few days If pregnant or breast-feeding, ask a health care professional before use.

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

Warnings For external use only Allergy alert: if prone to allergic reaction from aspirin or salicylates, consult a doctor before use When using this product ■ use only as directed. Read and follow all directions and warnings on this label. ■ avoid contact with eyes and mucous membranes ■ rare cases of serious burns have been reported with products of this type ■ do not apply to wounds or damaged, broken or irritated skin ■ do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use ■ do not use at the same time as other topical analgesics ■ a transient burning sensation may occur upon application but generally disappears in several days ■ if severe burning sensation occurs, discontinue use immediately ■ do not expose the area treated with product to heat or direct sunlight ■ avoid applying into skin folds Stop use and ask a doctor if ■ condition worsens ■ redness is present ■ irritation develops ■ symptoms persist for more than 7 days or clear up and occur again within a few days ■ you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied If pregnant or breast- feeding, ask a health professional before use.

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

Warnings For external use only Allergy alert: do not use if you are allergic to salicylates (including aspirin) unless directed by a doctor. Do not use ■ on wounds or on irritated or damaged skin ■ with a heating pad ■ at the same time as other topical analgesics When using this product ■ use only as directed ■ do not bandage tightly ■ avoid contact with eyes and mucous membranes ■ do not expose the area to local heat or to direct sunlight ■ rare cases of serious burns have been reported with products of this type ■ a transient burning sensation may occur upon application but generally disappears in several days ■ avoid applying into skin folds Stop use and ask a doctor if ■ condition worsens or symptoms persist for more than 7 days ■ symptoms clear up and occur again within a few days ■ redness is present or excessive skin irritation occurs ■ you experience severe burning pain, swelling, or blistering where the product was applied If pregnant or breast-feeding, ask a health professional before use.

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

🧪 Active Ingredient 21 words ▾

Active ingredient Menthol 10% Methyl salicylate 30%

Active ingredient Menthol 7.6% Methyl salicylate 29%

Active ingredient Menthol 10% Methyl salicylate 30%

🧪 Inactive Ingredients 59 words ▾

Inactive ingredients ceresin, cyclomethicone, hydrogenated castor oil, microcrystalline wax, paraffin, PEG-150 distearate, propylene glycol, stearic acid, stearyl alcohol (245-111) ICYHOT ® PAIN RELIEVING BALM Drug Facts

Inactive ingredients paraffin, white petrolatum ICYHOT ® PAIN RELIEVING CREAM Drug Facts

Inactive ingredients aminomethyl propanol, carbomer, cetearyl alcohol, cetyl esters, oleth-3 phosphate, polysorbate 60, stearic acid, water Replace cap after each use.

🎯 Purpose 9 words ▾

Purpose Topical analgesic

Purpose Topical analgesic

Purpose Topical analgesic

📄 Do Not Use 26 words ▾

Do not use ■ on wounds or on irritated or damaged skin ■ with a heating pad ■ at the same time as other topical analgesics

📄 When Using This Product ~1 min read ▾

When using this product ■ use only as directed. Read and follow all directions and warnings on this label. ■ avoid contact with eyes and mucous membranes ■ rare cases of serious burns have been reported with products of this type ■ do not apply to wounds or damaged, broken or irritated skin ■ do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use ■ a transient burning sensation may occur upon application but generally disappears in several days ■ if severe burning sensation occurs, discontinue use immediately ■ do not expose the area treated with product to heat or direct sunlight

When using this product ■ use only as directed. Read and follow all directions and warnings on this label. ■ avoid contact with eyes and mucous membranes ■ rare cases of serious burns have been reported with products of this type ■ do not apply to wounds or damaged, broken or irritated skin ■ do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use ■ do not use at the same time as other topical analgesics ■ a transient burning sensation may occur upon application but generally disappears in several days ■ if severe burning sensation occurs, discontinue use immediately ■ do not expose the area treated with product to heat or direct sunlight ■ avoid applying into skin folds

When using this product ■ use only as directed ■ do not bandage tightly ■ avoid contact with eyes and mucous membranes ■ do not expose the area to local heat or to direct sunlight ■ rare cases of serious burns have been reported with products of this type ■ a transient burning sensation may occur upon application but generally disappears in several days ■ avoid applying into skin folds

📄 Stop Use and Ask a Doctor If 136 words ▾

Stop use and ask a doctor if condition worsens redness is present irritation develops symptoms persist for more than 7 days or clear up and occur again within a few days

Stop use and ask a doctor if ■ condition worsens ■ redness is present ■ irritation develops ■ symptoms persist for more than 7 days or clear up and occur again within a few days ■ you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

Stop use and ask a doctor if ■ condition worsens or symptoms persist for more than 7 days ■ symptoms clear up and occur again within a few days ■ redness is present or excessive skin irritation occurs ■ you experience severe burning pain, swelling, or blistering where the product was applied

🤰 If Pregnant or Breast-Feeding 32 words ▾

If pregnant or breast-feeding, ask a health care professional before use.

If pregnant or breast- feeding, ask a health professional before use.

If pregnant or breast-feeding, ask a health professional before use.

📄 Keep Out of Reach of Children 57 words ▾

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

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

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

📄 Package Label / Principal Display Panel 106 words ▾

PRINCIPAL DISPLAY PANEL ICYHOT ® PAIN RELIEVING STICK EXTRA STRENGTH PAIN RELIEVING STICK Net wt 1. 7 5 oz ( 49 g) PRINCIPAL DISPLAY PANEL ICYHOT® PAIN RELIEVING STICK EXTRA STRENGTH Net wt 1.75 oz (49 g)

PRINCIPAL DISPLAY PANEL ICY HOT ® ORIGINAL PAIN RELI EF BALM N ET WT

3.5OZ (99.2 g) ICY HOT® ORIGINAL PAIN RELIEF BALM NET WT

3.5OZ (99.2 g) ICY HOT ORIGINAL PAIN RELIEF BALM

PRINCIPAL DISPLAY PANEL ICYHOT ® ORIGINAL CREAM PAIN RELIEF N ET WT 1. 25 oz (

35.4G ) PRINCIPAL DISPLAY PANEL ICYHOT® ORIGINAL CREAM PAIN RELIEF NET WT 1.25 oz (35.4 G)

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 Chattem, 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 tube (41167-0088-05). 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?
Chattem, 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.
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.