FDA.reportPublic FDA data

Chloraseptic Sore Throat Max

Product NDC
67172-937
11-digit product format
671720937
Labeler code
67172
Product ID
67172-937_f6d4fa49-df47-4ce2-8e9d-50d187d2473d
Type
HUMAN OTC DRUG
Nonproprietary name
Phenol and Glycerin
Dosage form
SPRAY
Route
ORAL
Labeler
Prestige Brands Holdings, Inc.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-02-01
Substance
PHENOL; GLYCERIN
Active strength
15; 330 mg/mL; mg/mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage67172-93767172-937-52DDiscontinued by firm2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 8 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Chloraseptic Sore Throat Max
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENOL15 mg/mL
GLYCERIN330 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
339NCG44TVInternal UNII lookup
PDC6A3C0OXInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1101852Internal RxNorm lookup
1101854Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
882c940c-b3c3-4aa4-8d64-e4260f066ff4Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67172-937-04Chloraseptic Sore Throat Max118 mL in 1 BOTTLE, DISPENSINGSPRAY1188
67172-937-04Chloraseptic Sore Throat Max1 in 1 BOXSPRAY18
67172-937-52Chloraseptic Sore Throat Max30 mL in 1 BOTTLE, DISPENSINGSPRAY308
67172-937-52Chloraseptic Sore Throat Max1 in 1 BOXSPRAY18

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLYCERINACTIVE INGREDIENTPDC6A3C0OXCHLORASEPTIC SORE THROAT MAX (PHENOL AND GLYCERIN) SPRAY [PRESTIGE BRANDS HOLDINGS, INC.]2
PHENOLACTIVE INGREDIENT339NCG44TVCHLORASEPTIC SORE THROAT MAX (PHENOL AND GLYCERIN) SPRAY [PRESTIGE BRANDS HOLDINGS, INC.]2
GLYCERINACTIVE MOIETYPDC6A3C0OXCHLORASEPTIC SORE THROAT MAX (PHENOL AND GLYCERIN) SPRAY [PRESTIGE BRANDS HOLDINGS, INC.]2
PHENOLACTIVE MOIETY339NCG44TVCHLORASEPTIC SORE THROAT MAX (PHENOL AND GLYCERIN) SPRAY [PRESTIGE BRANDS HOLDINGS, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCHLORASEPTIC SORE THROAT MAX (PHENOL AND GLYCERIN) SPRAY [PRESTIGE BRANDS HOLDINGS, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACHLORASEPTIC SORE THROAT MAX (PHENOL AND GLYCERIN) SPRAY [PRESTIGE BRANDS HOLDINGS, INC.]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCHLORASEPTIC SORE THROAT MAX (PHENOL AND GLYCERIN) SPRAY [PRESTIGE BRANDS HOLDINGS, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RCHLORASEPTIC SORE THROAT MAX (PHENOL AND GLYCERIN) SPRAY [PRESTIGE BRANDS HOLDINGS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67172-937CHLORASEPTIC SORE THROAT MAX (PHENOL AND GLYCERIN) SPRAY [PRESTIGE BRANDS HOLDINGS, INC.]7Current NDC, Legacy NDC, 4 package rows20250115_882c940c-b3c3-4aa4-8d64-e4260f066ff4.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 5 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sensitivity Relief Fluoride FreePOTASSIUM NITRATEHealth and Natural Beauty USA Corpc23b2a83-ebc3-4bcf-a216-7693944dcfa02026-05-22WarningsExact identifier
application number: M022
Sensitivity and Gum with Cavity ProtectionPOTASSIUM NITRATE AND SODIUM FLUORIDEHealth and Natural Beauty USA Corp137d6935-19a3-499d-957c-820156eec7a52026-05-22WarningsExact identifier
application number: M022
SEXYTEETH MINTY T00THPASTESEXYTEETH MINTY TOOTHPASTEWORLD DENTISTS ASSOCIATION AMERICA LIMITED51d288c1-fe86-ffe1-e063-6394a90ab4c42026-05-14WarningsExact identifier
application number: M022
Cepacol Extra Strength Sore Throat cherryBENZOCAINE AND MENTHOLReckitt Benckiser LLC941e36dd-d8d0-4e5c-8585-10e8f06bf8f02026-05-12WarningsExact identifier
application number: M022
Cepacol Extra Strength Sore Throat honey lemonBENZOCAINE AND MENTHOLReckitt Benckiser LLCd771095b-7de3-48f3-a125-8bc76e7d17782026-05-12WarningsExact identifier
application number: M022
SEXYTEETH CHARCOAL T00THPASTESEXYTEETH CHARCOAL TOOTHPASTEWORLD DENTISTS ASSOCIATION AMERICA LIMITED51ab8a9a-6c12-b13b-e063-6294a90ace2a2026-05-12WarningsExact identifier
application number: M022
365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash AnticavityFLUORIDEWHOLE FOODS25bc7ab1-116d-143a-e063-6394a90aa9702026-05-04WarningsExact identifier
application number: M022
Gingicaine Gel StrawberryGINGICAINE GEL STRAWBERRY FLAVORGingi-Pak a Division of the Belport2fd37612-a28b-3aa1-e054-00144ff8d46c2026-05-01WarningsExact identifier
application number: M022
3ECARE Dual formula WhiteningToothpaste RefillSODIUM FLUORIDEHangzhou Namei Zhikang Technology Co., Ltd.501df1c7-4884-bb39-e063-6294a90aaf6a2026-04-23WarningsExact identifier
application number: M022
Ora YoGu 4X Medicated Tooth and Gum Pain RelieverMEDICATED TOOTH AND GUM PAIN RELIEVERKungpo Health Care & Herbal Center Inc1f10a72f-0b49-41cb-92f9-b0160d7664de2026-04-22WarningsExact identifier
application number: M022
EverSmile AlignerFresh Enamel GuardSODIUM FLUORIDEEverbrands, Inc.7b3d0114-dac0-4370-8545-922ec018018e2026-04-21WarningsExact identifier
application number: M022
PREOPHYDROGEN PEROXIDEEverbrands, Inc.cc5cdd29-92c1-4ce0-997e-eb624b288b092026-04-20WarningsExact identifier
application number: M022
4x Medicated Toothache and Gum CreamBENZOCAINECVSa7576238-e7c8-7e86-e053-2995a90aaeb52026-04-20WarningsExact identifier
application number: M022
CVS Pharmacy Maximum StrengthBENZOCAINECVS Pharmacy92747826-cf58-4406-b3b5-12f7c7077c2c2026-04-20WarningsExact identifier
application number: M022
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLFamily Dollar (FAMILY WELLNESS)9f991292-bbaa-4f4e-b2cb-059d1a04849e2026-04-20WarningsExact identifier
application number: M022
Osstem S Sensitivity relief toothPOTASSIUM NITRATE, SODIUM FLUORIDEOsstem Pharma Co., Ltd4f8ab179-8f29-a7cf-e063-6294a90a0c222026-04-15WarningsExact identifier
application number: M022
Crest Pro-Health Gum DetoxifyWinter MintCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company4f6db58f-0b09-d155-e063-6394a90ae6582026-04-14WarningsExact identifier
application number: M022
Lolleez Orange MangoPECTINBFY LLC4f6dec8b-078a-f321-e063-6294a90a248c2026-04-14WarningsExact identifier
application number: M022
Crest Pro-Health Gum Restore Smooth MintCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company4f6e3b36-e565-7d27-e063-6294a90ae5ac2026-04-14WarningsExact identifier
application number: M022
Crest Pro-Health Nightly Bacteria ShieldCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company4f6ec1e0-c6b5-226f-e063-6294a90a8f142026-04-14WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1101854Chloraseptic Max Spray 33 % / 1.5 % Mucosal SprayPSN882c940c-b3c3-4aa4-8d64-e4260f066ff48
1101852glycerin 33 % / phenol 1.5 % Mucosal SprayPSN882c940c-b3c3-4aa4-8d64-e4260f066ff48
1101854glycerin 330 MG/ML / phenol 15 MG/ML Mucosal Spray [Chloraseptic Max Spray]SBD882c940c-b3c3-4aa4-8d64-e4260f066ff48
1101852glycerin 330 MG/ML / phenol 15 MG/ML Mucosal SpraySCD882c940c-b3c3-4aa4-8d64-e4260f066ff48
1101854Chloraseptic Max Spray (glycerin 33 % / phenol 1.5 % ) Mucosal SpraySY882c940c-b3c3-4aa4-8d64-e4260f066ff48
1101852glycerin 33 % / phenol 1.5 % Mucosal SpraySY882c940c-b3c3-4aa4-8d64-e4260f066ff48

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67172-937-04671720937041 BOTTLE, DISPENSING in 1 BOX (67172-937-04) / 118 mL in 1 BOTTLE, DISPENSING2021-06-010000-00-00NoNoCurrent
67172-937-52671720937521 BOTTLE, DISPENSING in 1 BOX (67172-937-52) > 30 mL in 1 BOTTLE, DISPENSING2011-02-010000-00-00NoNoCurrent