Home › NDC Lookup › Ingredients › Pramoxine Hydrochloride › 49967-0970-03
CeraVe Developed with Dermatologists Itch Relief Moisturizing pramoxine hydrochloride 1 mg/mL Lotion, 473 mL — NDC 49967-0970-03 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

CeraVe Developed with Dermatologists Itch Relief Moisturizing pramoxine hydrochloride 1 mg/mL Lotion, 473 mL — NDC 49967-970-03 (Billing 49967-0970-03)

by L'Oreal USA Products Inc · 473 mL in 1 BOTTLE

This is a package of 473 mL of CeraVe Developed with Dermatologists Itch Relief Moisturizing pramoxine hydrochloride 1 mg/mL Lotion from L'Oreal USA Products Inc, marketed since Aug 2017 and currently FDA-listed.

NDC 49967-0970-03
🏷️ FDA NDC (as labeled) 49967-970-03 billing pads the product segment with a zero
This package
Contains473 mL Pack sizes4 compare ↓
Product page 49967-0970-01 Also comes in: 15 bottles 49967-970-02 237 ml 49967-970-01 562 ml 49967-970-04
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 49967-970-03 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
49967 labeler · 970 product · 03 package
Package marketed since
Aug 17, 2017
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
3606000544017
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 49967-970-03
Product NDC 49967-970
11-digit billing NDC 49967097003
UNII 88AYB867L5
UPC 3606000544017
Application # M017
SPL Set ID 13ce57d0-b1c5-4685-ad7d-a562d9d8fc86
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-08-17
Route TOPICAL
Dosage form LOTION
Substance PRAMOXINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 49967-970-03 — 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 → 49967-0970-03. 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 gives short-term relief from pain and itching from minor problems like sunburn, minor burns, insect bites, and poison ivy rashes. Some products are made for specific uses, like...
  • That depends on the product. Many say not more than 3 to 4 times daily, and some allow up to 5 times daily. Check your label and follow it closely.
  • No. It is for external use only. If it gets in your eyes, rinse thoroughly with water.
  • Can I use it inside the vagina or near my eyes?
📖 Read our full Pramoxine 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.
Try another pack size: 15 bottles 237 ml 562 ml
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
49967-0970-01 49967-970-01 Main listing 237 mL in 1 BOTTLE, PUMP 2017-08-17 — Active
49967-0970-02 49967-970-02 15 BOTTLE in 1 TRAY / 29.6 mL in 1 BOTTLE 2017-08-17 — Active
49967-0970-03 You're viewing this 473 mL in 1 BOTTLE 2017-08-17 — Active
49967-0970-04 49967-970-04 562 mL in 1 BOTTLE 2017-08-17 — Active

Pack size FAQ

What quantity is in this package?
This package contains 473 mL — 473 ml in 1 bottle.
How does this package differ from NDC 49967-0970-02?
Both are CeraVe Developed with Dermatologists Itch Relief Moisturizing pramoxine hydrochloride 1 mg/mL Lotion — the drug itself is identical. This page's package is the 473 mL one, while NDC 49967-0970-02 is the 15 bottles package.
What NDC number is used to bill for this package of CeraVe Developed with Dermatologists Itch Relief Moisturizing pramoxine hydrochloride 1 mg/mL Lotion?
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
Sarna 10 mg/mL 00316-0230-75 Crown 222 ml — — Discontinued —
Walgreen Anti-Itch 1 g/100g 00363-0263-75 Walgreens 212 g — — FDA listed —
DerMend Moisturizing Anti-Itch 10 mg/mL 00496-0586-08 Ferndale 237 ml — — FDA listed —
Prax 10 mg/mL 00496-0748-03 Ferndale 237 ml — — FDA listed —
CeraVe Developed with Dermatologists Itch Relief Moisturizing 1 mg/mLthis 49967-0970-03 L'Oreal 473 ml — — FDA listed —
Prax 10 mg/mL 50268-0682-15 AvPAK 237 ml — — FDA listed —
CVS Itch relief moisturizing 1 g/100mL 51316-0144-01 CVS 237 ml — — FDA listed —
Pramoxine Hydrochloride Anorectal 1 mg/mL 58980-0522-40 Stratus 1 bottle — — FDA listed —
Peviderm Pramoxine Hydrocholride 1% 1 mg/mL 58980-0913-80 Stratus 1 bottle — — FDA listed —
CVS Anti-Itch 1 g/100g 69842-0263-75 CVS 212 g — — FDA listed —
Prosoria Anti-Itch Moisturizer .9 g/90mL 71573-0120-11 Nuvothera, 90 ml — — FDA listed —
Prequel Anti-Itch Solution Medicated Calming 1 g/100g 82800-0200-01 The 400 g — — 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

🏛️
2017
On the market since
Aug 2017
📍
2026
Currently FDA-listed
9 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 Pramoxine 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerL'Oreal USA Products Inc
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code49967
First marketedAug 2017
Product typeHuman Otc Drug
Portfolio199 products on file

More NDCs from L'Oreal USA Products Inc labeler code 49967

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 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 12 words ▾

Use For the temporary relief of itching associated with minor skin irritations

⏱️ 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 74 words ▾

Warnings For external use only When using this product do not get into eyes Stop use and ask a doctor if ▪ condition worsens ▪ symptoms last more than 7 days or clear up and occur again within a few days Do not use on ▪ deep or puncture wounds ▪ animal bites ▪ serious burns Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

🧪 Active Ingredient 5 words ▾

Active ingredient Pramoxine hydrochloride 1%

🧪 Inactive Ingredients 68 words ▾

Inactive ingredients water, isopropyl myristate, PEG-100 stearate, glyceryl stearate, cetearyl alcohol, cetyl alcohol, glycerin, niacinamide, dimethicone, stearic acid, allantoin, potassium phosphate, ceramide NP, ceramide AP, ceramide EOP, carbomer, zinc citrate, behentrimonium methosulfate, sodium hydroxide, sodium lauroyl lactylate, arginine PCA, myristic acid, sodium PCA, cholesterol, palmitic acid, tasmannia lanceolata fruit extract, phenoxyethanol, dipotassium phosphate, disodium EDTA, alcohol denat., tocopheryl acetate, hydrolyzed hyaluronic acid, xanthan gum, phytosphingosine, polyglyceryl-3 diisostearate, ethylhexylglycerin

🎯 Purpose 3 words ▾

Purpose External analgesic

📄 Do Not Use 15 words ▾

Do not use on ▪ deep or puncture wounds ▪ animal bites ▪ serious burns

📄 When Using This Product 9 words ▾

When using this product do not get into eyes

📄 Stop Use and Ask a Doctor If 42 words ▾

Stop use and ask a doctor if ▪ condition worsens ▪ symptoms last more than 7 days or clear up and occur again within a few days Do not use on ▪ deep or puncture wounds ▪ animal bites ▪ serious burns

📄 Keep Out of Reach of Children 18 words ▾

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

📄 Questions or Comments 5 words ▾

Questions? Toll-Free Number 888-768-2915 www.cerave.com

📄 Package Label / Principal Display Panel 13 words ▾

image of a front label

image of a back label

carton front back

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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 L'Oreal USA Products 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 3 other package presentations of this same product, including 15 bottles (49967-0970-02), 237 ml (49967-0970-01), 562 ml (49967-0970-04). 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?
L'Oreal USA Products 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.
← 49967-0969-01 · L'Oreal 49967-0971-01 · L'Oreal →
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.