Home › NDC Lookup › 50967-0357-60
Procort 1.85% hydrocortisone acetate - 1.15% pramoxine hci cream 18.5 mg/g; 11.5 mg/g Cream — NDC 50967-0357-60 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Procort 1.85% hydrocortisone acetate - 1.15% pramoxine hci cream 18.5 mg/g; 11.5 mg/g Cream — NDC 50967-357-60 (Billing 50967-0357-60)

by Womens Choice Pharmaceuticals LLC · 1 TUBE, WITH APPLICATOR in 1 CARTON / 1 TUBE, WITH APPLICATOR in 1 TUBE, WITH APPLICATOR / 60 g in 1 TUBE, WITH APPLICATOR

This is a package of Procort 1.85% hydrocortisone acetate - 1.15% pramoxine hci cream 18.5 mg/g; 11.5 mg/g Cream from Womens Choice Pharmaceuticals LLC, marketed since Jun 2011 and currently FDA-listed. It is this product's only package size.

NDC 50967-0357-60
🏷️ FDA NDC (as labeled) 50967-357-60 billing pads the product segment with a zero
Rx only On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 50967-357-60 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
50967 labeler · 357 product · 60 package
Package marketed since
Jun 30, 2011
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5096735760 1
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 50967-357-60
Product NDC 50967-357
11-digit billing NDC 50967035760
NCPDP billing unit GM — per gram (weight)
RxCUI 1114854, 1115730
UNII 3X7931PO74, 88AYB867L5
SPL Set ID 9e899b72-a16e-4b55-93b5-ab5baec37d50
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2011-06-30
Route TOPICAL
Dosage form CREAM
Substance HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE

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

GPI-14 89991002313714
GPI class ProCort
GCN Seq No 067513
GCN 30091
HICL code 015163
Ingredient (HICL) Hydrocortisone/Pramoxine
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q3
Therapeutic class — intermediate (HIC2) Anal-Rectal Preparations
HIC3 code Q3I
Therapeutic class — specific (HIC3) Hemorrhoid Prep,Anti-Inflam Steroid-Local Anesthet
AHFS code 84:06.08.00
AHFS class Corticosteroids (Skin, Mucous Membrane)
FDB label name PROCORT 1.85%-1.15% CREAM
FDB brand name Procort
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 067513
  • GCN: 30091
  • GPI-14 (Medi-Span): 89991002313714
  • HICL (First Databank): 015163
  • AHFS class code: 84:06.08.00
  • RxCUI (RxNorm): 1114854
Why two NDCs? The FDA registers this code as 50967-357-60 — 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 → 50967-0357-60. 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 Local anesthetics class.

Drug family (ATC) Local anesthetics, Anesthetics for topical use
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

Label name PROCORT 1.85%-1.15% CREAM Ingredient Hydrocortisone/Pramoxine
📖 About the active ingredient MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.

Rectal hydrocortisone is used along with other medications to treat proctitis (swelling in the rectum) and ulcerative colitis (a condition which causes swelling and sores in the lining of the large intestine and rectum). It is also used to relieve itching and swelling from hemorrhoids and other rectal problems. 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 ↗
🧪 What is this product?

Procort is a topical cream containing two active ingredients: hydrocortisone acetate, a corticosteroid typically used to reduce inflammation and itching, and pramoxine hydrochloride, a local anesthetic commonly used to numb pain and itching. This product is marketed as an unapproved drug and has not received FDA approval through a standard application process.

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
50967-0357-60 You're viewing this Main listing 1 TUBE, WITH APPLICATOR in 1 CARTON / 1 TUBE, WITH APPLICATOR in 1 TUBE, WITH APPLICATOR / 60 g in 1 TUBE, WITH APPLICATOR 2011-06-30 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Procort 18.5 mg/g; 11.5 mg/gthis 50967-0357-60 Womens 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

🏛️
2011
On the market since
Jun 2011
📍
2026
Currently FDA-listed
15 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII H4N855PNZ1
    Alpha-tocopherol is a form of vitamin E, a fat-soluble antioxidant derived from natural or synthetic sources. In medicines, it prevents oils and fats from breaking down and becoming rancid, protecting the product's stability and shelf life.
  • UNII CZ7BU4QZJZ
    A synthetic organic compound used as a buffer in medicines. It helps maintain the pH (acidity or alkalinity) of liquid formulations to keep the medication stable and suitable for use.
  • UNII 389H2R62BD
    A synthetic polymer made from chemicals that form a plastic-like substance. It acts as a binder and film-former to help hold tablet ingredients together and may provide a protective coating on the medicine.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII 1S66E28KXA
    Poloxamer 124 is a synthetic polymer that acts as a surfactant and solubilizer in medicines. It helps dissolve and stabilize active ingredients, particularly in liquid formulations and gels.
  • 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.

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

LabelerWomens Choice Pharmaceuticals LLC
Labeler code50967
First marketedJun 2011
Product typeHuman Prescription Drug
Portfolio4 products on file

More NDCs from Womens Choice Pharmaceuticals LLC labeler code 50967

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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description ⚠️ Precautions 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 16 words ▾

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

⏱️ Dosage and Administration 132 words ▾

topical corticosteroids are generally applied to the affected area as a thin film 3 to 4 times daily, depending on the severity of the condition. Occlusive dressing may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

Directions for rectal administration: 1. To open, remove foil, tab or puncture foil seal with cap. 2.

Remove the applicator’s wrapping and attach the applicator to the tube. 3. Squeeze the tube to fill the applicator and lubricate the tip with cream.

4. Gently insert the applicator into rectum and squeeze tube begin to force the required amount of cream into rectum. 5.

Wipe applicator tip clean remove and discard. 6. Securely apply screw cap on tube.

⛔ Contraindications 20 words ▾

Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

🤒 Adverse Reactions 38 words ▾

The following local adverse reactions are reported in frequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence; itching, burning, skin irritation.

🆘 Overdosage 15 words ▾

topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. (See precautions.)

🧬 Clinical Pharmacology 220 words ▾

Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of topical corticosteroids is unclear. Various laboratory methods, including a vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids.

There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man. Pramoxine hydrochloride is a topical anesthetic agent which provides temporary relief from itching and pain. It acts by stabilizing the neuronal membrane of nerve endings with which it comes into contact.

Pharmacokinetics: The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption.

Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses. (See DOSAGE AND ADMINISTRATION.) Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids.

Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

📦 How Supplied / Storage and Handling 47 words ▾

hydrocortisone acetate 1.85%, Pramoxine HCL 1.15% is a topical cream and supplied in the following: 60 gram tube kit (NDC# 50967–357–60), each containing a 60 g tube and/15 single use app applicators. 2 gram Sample Kit (NDC# 50967–357–02), each containing a 2g tube and/1 single use applicator

📦 Storage and Handling 31 words ▾

ProCort® insert registered symbol,storage condition: store at 25°C (77°F); excursions permitted to 15–30°C (59 to 86°F.)[see USP controlled room temperature]. Rx only. Distributed by: Women’s Choice, Pharmaceuticals, Berwyn, PA 19312 Www.wcpharma.com

📋 Description 82 words ▾

DESCRIPTION: ProCort® is a topical preparation containing hydrocortisone acetate 1.85% and pramoxine hydrochloride 1.15% in a hydrophilic and hydrophobic cream base which contains patented *Invisicare M1 polymer technology. Active Ingredients: Hydrocortisone Acetate 1.85%, Pramoxine HCL 1.15% Inactive Ingredients: Polysorbate-60, Poloxamer 124, PVM/MA copolymer VP/Hexadecene copolymer VP/Eicosene copolymer, Tocopheryl acetate, Aminomethyl propanediol, Stearic Acid, Phenoxyethanol, and Sterilized Water. Topical corticosteroids are anti-inflammatory and anti-pruritic agents.

The structural formula, the chemical name, molecular formula and molecular weight for active ingredients are presented below. formula

⚠️ Precautions ~3 min read ▾

General: Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients. Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area and under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests.

If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity. (See Precautions-Pediatric Use.) If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted.

If a favorable response does not occur promptly the corticosteroid should be discontinued until the infection has been adequately controlled. Information for the Patient: Patients using topical corticosteroids should receive the following information and instructions: 1. This medications is to be used as directed by the physician.

It is for external use only. Avoid contact with the eyes. 2.

Patients should be advised not to use this medication for any disorder other than for which it was prescribed. 3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.

4. Patient should report any signs of local adverse reactions especially under occlusive dressings. 5.

Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garment may constitute occlusive dressings. Laboratory Tests: The following tests may be helpful in evaluating the HPA axis suppression: Urinary free cortisol test. ACTH stimulation test Carcinogenesis, mutagenesis, and Impairment of Fertility: Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.

Studies to determine mutagenecity with prednisolone and hydrocortisone have revealed negative results. Pregnancy: Teratogenic Effects: Pregnancy Category C: Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent coricosteroids have been shown to be teratogenic after dermal application in laboratory animals.

There are no adequate and well-controlled studeis in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

Nursing Mothers:It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable amounts in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantitites NOT likely to have deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

Pediatric Use: Pediatric patients may demonstrate greater s… [Excerpted — this section continues on DailyMed.]

📄 Patient Package Insert 4 words ▾

PROCORT ® packageinsert pi2

📄 Package Label / Principal Display Panel ~2 min read ▾

label ProCort carton for 60g NDC 50967-357-60 Rx Only See product literature for complete information. Contents: Each gram of ProCort contains 1.85% (18.5 mg) Hydrocortisone acetate and 1.15% (11.5 mg) Pramoxine hydrochloride (HCI). Also contains 6% M1 polymer.

Inactive ingredients: Polysorbate-60, Poloxamer 124, PVM/MA copolymer VP/Hexadecene copolymer VP/Eicosene copolymer, Tocopheryl acetate, Aminomethyl propanediol, Stearic Acid, Phenoxyenthanol, and Sterilized Water. Dosage: Apply to affected are 3 - 4 times daily or as directed by your physician Warning: Keep out of reach of children. Not fur use under diapers or occlusive dressings without physician supervision. for externam use only.

Avoid contact with eyes. May discolor fabrics. Storage: Store at room temperature 15°-30°C (59°-86°F).

Keep tightly closed. To Open: Remove foil tab or puncture foil seal with cap. Applicator: Use applicator tip as directed by your physician.

DIRECTIONS FOR RECTAL ADMINISTRATION: 1. To open, remove foil tab or puncture foil seal with cap. 2.

Remove the applicator's wrapping and attach the applicator to the tube. 3. Squeeze the tube to fill the applicator and libricate the tip with cream.

4. Gently insert the applicator into rectum and squeeze tube again to force the required amount of cream into rectum. 5.

Wipe applicator tip clean, remove and discard. 6. Securely apply screw cap on tube.

NDC 50967-357-60 ProCort 1.85% hydrocortisone acetate - 1.15% pramoxine HCI FOR EXTERNAL USE ONLY Net Weight 60.0g (2.12 oz) Distributed by: Women's Choice Pharmaceuticals, Gilbert, AZ 85233 www.wcpharma.com 877-774-4949 Invisicare® M1 Plymer Patent Numbers: 7,674,471, 6,756,059, 6,582,683

ProCort carton for 60g NDC 50967-357-60 Rx Only See product literature for complete information. Contents: Each gram of ProCort contains 1.85% (18.5 mg) Hydrocortisone acetate and 1.15% (11.5 mg) Pramoxine hydrochloride (HCI). Also contains 6% M1 polymer.

Inactive ingredients: Polysorbate-60, Poloxamer 124, PVM/MA copolymer VP/Hexadecene copolymer VP/Eicosene copolymer, Tocopheryl acetate, Aminomethyl propanediol, Stearic Acid, Phenoxyenthanol, and Sterilized Water. Dosage: Apply to affected are 3 - 4 times daily or as directed by your physician Warning: Keep out of reach of children. Not fur use under diapers or occlusive dressings without physician supervision. for externam use only.

Avoid contact with eyes. May discolor fabrics. Storage: Store at room temperature 15°-30°C (59°-86°F).

Keep tightly closed. To Open: Remove foil tab or puncture foil seal with cap. Applicator: Use applicator tip as directed by your physician.

DIRECTIONS FOR RECTAL ADMINISTRATION: 1. To open, remove foil tab or puncture foil seal with cap. 2.

Remove the applicator's wrapping and attach the applicator to the tube. 3. Squeeze the tube to fill the applicator and libricate the tip with cream.

4. Gently insert the applicator into rectum and squeeze tube again to force the required amount of cream into rectum. 5.

Wipe applicator tip clean, remove and discard. 6. Securely apply screw cap on tube.

NDC 50967-357-60 ProCort 1.85% hydrocortisone acetate - 1.15% pramoxine HCI FOR EXTERNAL USE ONLY Net Weight 60.0g (2.12 oz) Distributed by: Women's Choice Pharmaceuticals, Gilbert, AZ 85233 www.wcpharma.com 877-774-4949 Invisicare® M1 Plymer Patent Numbers: 7,674,471, 6,756,059, 6,582,683

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

Finished prescription product Marketed without an FDA application

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

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 "Unapproved Drug Other". 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 Womens Choice Pharmaceuticals LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Womens Choice Pharmaceuticals LLC 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 a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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.
← 50967-0317-30 · WOMENS 50967-0410-30 · Womens →
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.