Home › NDC Lookup › Ingredients › Phenol Glycerin › 00363-8910-04
Sore Throat Phenol Glycerin 1.5 mg/100mL; 33 mg/100mL Spray, 118 mL — NDC 00363-8910-04 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Sore Throat Phenol Glycerin 1.5 mg/100mL; 33 mg/100mL Spray, 118 mL — NDC 0363-8910-04 (Billing 00363-8910-04)

by Walgreens · 118 mL in 1 BOTTLE, SPRAY

This is a package of 118 mL of Sore Throat Phenol Glycerin 1.5 mg/100mL; 33 mg/100mL Spray from Walgreens, marketed since Apr 2025 and currently FDA-listed. It is this product's only package size.

NDC 00363-8910-04
🏷️ FDA NDC (as labeled) 0363-8910-04 billing pads the labeler segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 27, 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0363-8910-04
Product NDC 0363-8910
11-digit billing NDC 00363891004
RxCUI 1101852
UNII 339NCG44TV, PDC6A3C0OX
Application # M022
SPL Set ID 1e845299-178e-49ce-9d08-7e9d548a5a6d
Established class (EPC) Non-Standardized Chemical Allergen
Physiologic effect Increased Histamine Release; Cell-mediated Immunity; Increased IgG Production
Chemical class Allergens; Glycerol
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-04-18
Route ORAL
Dosage form SPRAY
Substance PHENOL; GLYCERIN
Quick answers
  • RxCUI (RxNorm): 1101852
Why two NDCs? The FDA registers this code as 0363-8910-04 — 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 → 00363-8910-04. 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 Sclerosing agents for local injection class.

Drug family (ATC) Sclerosing agents for local injection, Phenol and derivatives, Other local anesthetics
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

🧪 What is this product?

This is an over-the-counter spray for sore throat relief marketed as an OTC monograph product. It contains phenol, a topical anesthetic commonly used to numb minor throat pain and irritation, and glycerin, a humectant that typically helps soothe and moisturize the throat lining. The spray is applied directly to the mouth and throat area to provide temporary relief from sore throat discomfort.

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 mLPer 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
00363-8910-04 You're viewing this Main listing 118 mL in 1 BOTTLE, SPRAY 2025-04-18 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sore Throat 1.5 mg/100mL; 33 mg/100mLthis 00363-8910-04 Walgreens 118 ml — — FDA listed —
meijer Maximum Strength Sore Throat Fast Relief 15 mg/mL; 330 mg/mL 41250-0764-01 MEIJER 1 bottle — — FDA listed —
Sore Throat 1.5 mg/100mL; 33 mg/100mL 51316-0199-04 CVS 118 ml — — FDA listed —
Chloraseptic Sore Throat Max 15 mg/mL; 330 mg/mL 67172-0937-04 Prestige 1 bottle — — 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

🏛️
2025
On the market since
Apr 2025
📍
2026
Currently FDA-listed
1 year 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.

What it looks like

Color purple
FlavorBerry
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 H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII SB8ZUX40TY
    Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
  • UNII 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • 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.

The official label also statesFD&C blue # 1, FD&C red #40, flavor, purified water, saccharin sodium, sucralose

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

LabelerWalgreens
FDA applicationM022 (OTC MONOGRAPH DRUG)
Labeler code00363
First marketedApr 2025
Product typeHuman Otc Drug
Portfolio342 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 ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 28 words ▾

Uses for the temporarily relief of occasional minor irritation, pain, sore mouth, and sore throat minor discomfort and protection of irritated areas in sore mouth and sore throat

⏱️ Dosage and Administration 66 words ▾

Directions adults and children 2 years of age and older: apply to affected area (one spray) allow to remain in place for at least 15 seconds, then spit out use every 2 hours as directed by a dentist or doctor children under 12 years of age should be supervised in the use of this product children under 6 years of age: consult a dentist or doctor

⚠️ Warnings 128 words ▾

Warnings Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days.

When using this product, do not exceed recommended dose. Stop use and ask a dentist or doctor if sore throat is severe, or lasts for more than 2 days sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsens fever, headache, rash, swelling, nausea or vomiting develops If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.

If more than used for minor mouth or throat pain is accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

📦 Storage and Handling 9 words ▾

Other information store between 20-25ºC (68-77ºF). Do not refrigerate.

🧪 Active Ingredient 6 words ▾

Active ingredient Glycerin 33% Phenol 1.5%

🧪 Inactive Ingredients 15 words ▾

Inactive ingredients FD&C blue # 1, FD&C red #40, flavor, purified water, saccharin sodium, sucralose

🎯 Purpose 5 words ▾

Purpose Oral demulcent Oral anesthetic/analgesic

📄 When Using This Product 9 words ▾

When using this product, do not exceed recommended dose.

📄 Stop Use and Ask a Doctor If 44 words ▾

Stop use and ask a dentist or doctor if sore throat is severe, or lasts for more than 2 days sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsens fever, headache, rash, swelling, nausea or vomiting develops

🤰 If Pregnant or Breast-Feeding 10 words ▾

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

📄 Keep Out of Reach of Children 31 words ▾

Keep out of reach of children. If more than used for minor mouth or throat pain is accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

📄 Questions or Comments 8 words ▾

Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

📄 Package Label / Principal Display Panel 121 words ▾

Principal Display Panel Compare to the active ingredients in Chloraseptic® Max Strength Sore Throat Spray†† SORE THROAT SPRAY Oral Relief GLYCERIN 33% / ORAL DEMULCENT PHENOL 1.5% / ORAL ANESTHETIC / ANALGESIC Maximum Strength Fast Acting Numbs throat in seconds for ages 2 years & older Berry Flavored FL OZ (mL) ††This product is not manufactured or distributed by Prestige Consumer Healthcare, Inc, distributor of Chloraseptic® Max Strength Sore Throat Spray. TAMPER EVIDENT: Do not use if imprinted shrink band is broken or missing.

For Lot and Expiration Date, see bottom of bottle. Keep cap on when not in use. DISTRIBUTED BY: WALGREENS CO., DEERFIELD, IL 60015

Package Label WALGREENS Maximum Strength Sore Throat Spray Berry Flavor Glycerin 33% Phenol 1.5%

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Sore Throat (this brand).

Top reported reactions

Dyspnoea20
Vomiting19
Acute Kidney Injury18
Diarrhoea16
Fatigue16
Nausea16
Abdominal Pain14

Age at onset

Child2
Adolescent1
Adult22
Elderly15

Reporter sex

250 reports
Male · 39%
Female · 61%

Serious outcomes

Hospitalization120
Disabling10
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 21 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

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 Walgreens. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Walgreens 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.
← 00363-8901-24 · WALGREEN 00363-8970-20 · Walgreens →
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.