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Family Wellness Hot and Cold Pain Relief 100 mg/g; 300 mg/g Cream, 1 tube — NDC 55319-0824-35 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Family Wellness Hot and Cold Pain Relief 100 mg/g; 300 mg/g Cream, 1 tube — NDC 55319-824-35 (Billing 55319-0824-35)

by FAMILY DOLLAR (Family Wellness) · 1 TUBE in 1 CARTON / 35.4 g in 1 TUBE

This is a package of 1 tube of Family Wellness Hot and Cold Pain Relief 100 mg/g; 300 mg/g Cream from FAMILY DOLLAR (Family Wellness), marketed since Sep 2023 and currently FDA-listed. It is this product's only package size.

NDC 55319-0824-35
🏷️ FDA NDC (as labeled) 55319-824-35 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 55319-824-35 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
55319 labeler · 824 product · 35 package
Package marketed since
Sep 30, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5531982435 0
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 55319-824-35
Product NDC 55319-824
11-digit billing NDC 55319082435
RxCUI 311500
UNII L7T10EIP3A, LAV5U5022Y
Application # M017
SPL Set ID b70e343b-18aa-4e45-ae8e-79d8c84ad205
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-09-30
Route TOPICAL
Dosage form CREAM
Substance MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE
Quick answers
  • RxCUI (RxNorm): 311500
Why two NDCs? The FDA registers this code as 55319-824-35 — 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 → 55319-0824-35. 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

📗 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 →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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
55319-0824-35 You're viewing this Main listing 1 TUBE in 1 CARTON / 35.4 g in 1 TUBE 2023-09-30 — Active

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/100g 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/gthis 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

🏛️
2023
On the market since
Sep 2023
📍
2026
Currently FDA-listed
3 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 4Q93RCW27E
    A synthetic polymer made from acrylic acid that's crosslinked for stability. It acts as a thickener and gelling agent in creams and gels, helping the medicine spread evenly and maintain its texture.
  • UNII 8NLQ36F6MM
    Edetate disodium anhydrous is a chemical compound that binds to metal ions in a medicine. It's used as a stabilizer to prevent unwanted chemical reactions and help keep the drug product effective during storage.
  • 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 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII WZH3C48M4T
    Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
  • 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.

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

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

LabelerFAMILY DOLLAR (Family Wellness)
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code55319
First marketedSep 2023
Product typeHuman Otc Drug
Portfolio63 products on file

More NDCs from FAMILY DOLLAR (Family Wellness) labeler code 55319

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 22 words ▾

Uses For temporary relief of minor aches and pains of muscle and joints associated with; simple backaches, arthritis, strains, bruises and sprains

⏱️ Dosage and Administration 35 words ▾

Directions Use only as directed 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; ask a doctor.

⚠️ Warnings 42 words ▾

Warning For external use only Do not use on wounds or damaged skin with a heating pad on a child under 12 years of age with arthritis-like condiitions Ask a doctor before use if you have ; redness over thre affected area

🧪 Active Ingredient 8 words ▾

Active ingredients Menthol - 10% Methyl salicylate -30%

🧪 Inactive Ingredients 2 words ▾

Inactive ingredients

🎯 Purpose 5 words ▾

Purpose Topical Analgesic Topical Analgesic

📄 When Using This Product 15 words ▾

When using this product avoid contact with eyes and mucous membranes do not bandage tightly

📄 Stop Use and Ask a Doctor If 31 words ▾

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 excessive skin irritation occur

📄 Keep Out of Reach of Children 23 words ▾

Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

📄 Other Information 13 words ▾

Other information Store at controlled room temperature 20°- 25°C ( 68° to 77°F)

📄 Questions or Comments 3 words ▾

Questions? 1-800 814-8028

📄 Package Label / Principal Display Panel 51 words ▾

Principal Display Panel -Tube Family Wellness NDC 55319-824-35 Cold & Hot Pain Relief Cream MENTHOL 10% METHYL SALICYLATE 30% NET WT

1.25OZ (35.4g) FD_ColdHot PainRelief_Tube

Principal Display Panel -Carton Family Wellness NDC 55319-824-35 Cold & Hot Pain Relief Cream MENTHOL 10% METHYL SALICYLATE 30% NET WT

1.25OZ (35.4g) FD_ColdHotPainRelief_Carton

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 FAMILY DOLLAR (Family Wellness). Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
FAMILY DOLLAR (Family Wellness) 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.
← 55319-0822-50 · FAMILY 55319-0826-28 · FAMILY →
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.