Home › NDC Lookup › 00813-0799-55
Fem pH Acetic Acid and Oxyquinoline sulfate .009; .00025 g/g; g/g Jelly, 50 g — NDC 00813-0799-55 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Fem pH Acetic Acid and Oxyquinoline sulfate .009; .00025 g/g; g/g Jelly, 50 g — NDC 0813-0799-55 (Billing 00813-0799-55)

by Pharmics, Inc. · 50 g in 1 TUBE

This is a package of 50 g of Fem pH Acetic Acid and Oxyquinoline sulfate .009; .00025 g/g; g/g Jelly from Pharmics, Inc., no longer marketed, no longer in the FDA NDC Directory. It is this product's only package size.

NDC 00813-0799-55
🏷️ FDA NDC (as labeled) 0813-0799-55 billing pads the labeler segment with a zero
Rx only Discontinued Non-controlled ⚠ Inactivated by FDA ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 14, 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 0813-0799-55 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0813 labeler · 0799 product · 55 package
Billing quantity
50 g per package
Barcode (UPC-A, from the NDC)
3 0813079955 0
FDA record last changed
Jul 14, 2026
⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2024. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0813-0799-55
Product NDC 0813-0799
11-digit billing NDC 00813079955
NCPDP billing unit GM — per gram (weight)
SPL Set ID 77237c50-aeb5-44a0-a1e6-ce1551b49f75
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2024)
Route VAGINAL
Dosage form JELLY
Substance ACETIC ACID; OXYQUINOLINE SULFATE

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

GCN Seq No 043116
GCN 92536
HICL code 020397
Ingredient (HICL) Acetic Acid/Oxyquinoline
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q4
Therapeutic class — intermediate (HIC2) Vaginal Preparations
HIC3 code Q4B
Therapeutic class — specific (HIC3) Vaginal Antiseptics
AHFS code 84:04.92.00
AHFS class Local Anti-Infectives, Miscellaneous
FDB label name FEM PH VAGINAL JELLY
FDB brand name Fem Ph
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 043116
  • GCN: 92536
  • HICL (First Databank): 020397
  • AHFS class code: 84:04.92.00
Why two NDCs? The FDA registers this code as 0813-0799-55 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00813-0799-55. 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 FEM PH VAGINAL JELLY Ingredient Acetic Acid/Oxyquinoline

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 eachPer 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
00813-0799-55 You're viewing this Main listing 50 g in 1 TUBE 1999-07-15 — Inactivated by FDA

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Fem pH .009; .00025 g/g; g/gthis 00813-0799-55 Pharmics, 50 g — — Discontinued —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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.

What it looks like

Color white
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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 PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 33X04XA5AT
    Lactic acid is a naturally occurring organic acid derived from milk or plant sources. It lowers and maintains pH in formulations, helps preserve the product, and can enhance ingredient stability and absorption.
  • UNII TVH7653921
    A synthetic polymer derived from ethylene glycol that acts as a humectant and solvent in medicines. It helps keep the product moist and aids in dissolving or dispersing active ingredients throughout the formulation.
  • 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 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.

5 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

LabelerPharmics, Inc.
Labeler code00813
Product typeHuman Prescription Drug
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. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 22 words ▾

Indications and Usage Fem pH is indicated as adjunctive therapy in those cases where restoration and maintenance of vaginal acidity is desirable.

⏱️ Dosage and Administration 135 words ▾

Dosage and Administration The usual dose is one applicator full, administered intra-vaginally, morning and evening. Duration of treatment may be determined by the patient's response to therapy. Each tube has a tamper evident seal at the opening of the tube.

Replace cap after each use. To fill applicator screw applicator clockwise onto the tube. Squeeze tube forcing Fem pH jelly into barrel until it is full.

Then unscrew applicator counter-clockwise to remove from tube. Lie on your back with knees drawn up. Hold filled applicator by the barrel and gently insert it into the vagina as far as it will comfortably go.

Press plunger to empty the contents. Keep the plunger depressed and remove the applicator from vagina. After each use pull applicator apart and wash with warm soapy water, rinse well, dry and reassemble.

⛔ Contraindications 3 words ▾

Contraindications None known.

⚠️ Warnings 19 words ▾

Warnings No serious adverse reactions or potential safety hazard have been reported with the use of Fem pH .

🤒 Adverse Reactions 12 words ▾

Adverse Reactions Occasional cases of local stinging and burning have been reported.

🔄 Drug Interactions 20 words ▾

Drug Interactions No incidence of drug interactions has been reported with concomitant use of Fem pH and any other medication.

🤰 Pregnancy 50 words ▾

Pregnancy Pregnancy Category C Animal reproduction studies have not been conducted with Fem pH . It is not known whether Fem pH can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Fem pH should be given to a pregnant woman only if clearly needed.

🧬 Clinical Pharmacology 16 words ▾

Clinical Pharmacology Fem pH acts to restore and maintain normal vaginal acidity through its buffered action.

📦 How Supplied / Storage and Handling 41 words ▾

How Supplied 50g Tube (NDC 00813-0799-55) with Fem pH applicator. Keep this and all medication out of the reach of children. In case of accidental overdose, call a doctor or poison control center immediately. Store at controlled room temperature 59°-86°F (15°-30°C)

📦 Storage and Handling 31 words ▾

Keep this and all medication out of the reach of children. In case of accidental overdose, call a doctor or poison control center immediately. Store at controlled room temperature 59°-86°F (15°-30°C)

📋 Description 66 words ▾

Description Fem pH Vaginal Jelly is a bland, non-irritating water dispersible, buffered acid jelly for intravaginal use. Fem pH is classified as a Vaginal Therapeutic Jelly. Fem pH contains 0.9% glacial acetic acid (C2H402) and 0.025% oxyquinoline sulfate (C18H16N206S) compounded with glycerin, lactic acid, poly ethylene glycol 4500 and purified water. Fem pH is formulated to pH 3.8-4.3 and is adjusted using 1 N potassium hydroxide.

⚠️ Precautions 167 words ▾

Precautions General No special care is required for the safe and effective use of Fem pH . Drug Interactions No incidence of drug interactions has been reported with concomitant use of Fem pH and any other medication. Laboratory Tests The monitoring of vaginal acidity (pH) may be helpful in following the patient's response.

(The normal vaginal pH has been shown to be in the range of 4.0 to 5.0) Carcinogenesis No long-term studies in animals have been performed to evaluate carcinogenic potential. Pregnancy Pregnancy Category C Animal reproduction studies have not been conducted with Fem pH . It is not known whether Fem pH can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Fem pH should be given to a pregnant woman only if clearly needed. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Fem pH is administered to a nursing woman.

🍼 Nursing Mothers 35 words ▾

Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Fem pH is administered to a nursing woman.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 13 words ▾

Carcinogenesis No long-term studies in animals have been performed to evaluate carcinogenic potential.

📖 Instructions for Use 120 words ▾

Therapeutic Vaginal Jelly Directions for using Fem pH applicator. Each tube has a tamper evident seal at the opening of the tube. Replace cap after each use.

To fill applicator screw applicator clockwise onto the tube. Squeeze tube forcing Fem pH jelly into barrel until it is full. Then unscrew applicator counter-clockwise to remove from tube.

Lie on your back with knees drawn up. Hold filled applicator by the barrel and gently insert it into the vagina as far as it will comfortably go. Press plunger to empty the contents.

Keep the plunger depressed and remove the applicator from vagina. After each use pull applicator apart and wash with warm soapy water, rinse well, dry and reassemble. Figure Figure Figure

📄 Package Label / Principal Display Panel 23 words ▾

PRINCIPAL DISPLAY PANEL - 50g Tube Box NDC 00813-0799-55 Rx Only Fem pH™ Therapeutic Vaginal Jelly Net Weight 50g (1.66 oz.) pharmicsINC label

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 No longer marketed (per FDA listing data)

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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Who lists this product with the FDA?
Pharmics, 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 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.
← 00802-2685-94 · Humco 00832-0038-00 · Upsher-Smith →
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.