FDA.reportPublic FDA data

SUGAR FREE ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS

Manufacturer
Ricola Ag
Effective date
2024-12-05
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:40:39

Label at a glance#

ProductSUGAR FREE ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS
Active ingredientMENTHOL
Label structure10 sections

Indications and uses

temporarily relieves: cough due to a cold or inhaled irritants occasional minor irritation and pain due to sore throat or sore mouth

Dosage and administration

adults and children 6 years and older:  dissolve 2 drops (one at a time) slowly in the mouth.  Repeat every 2 hours as needed or as directed by a doctor children under 6 years: ask a doctor

Storage and handling

Phenylketonurics: contains phenylalanine 1 mg per drop excessive use may have a laxative effect store in a dry place product may be useful for diabetics on the advice of a doctor Exchange information:   2 Drops = FREE Exchange                                                 7 Drops = 1 Fruit Dietary exchanges based on Exchange Lists for Diabetics © 2008 American Diabetes Association, American Dietetic Association

Label contents#

Full prescribing information#

Drug Facts

OTC - PURPOSE SECTION

Purpose

Cough suppressant, Oral anesthetic

Active Ingredient (in each drop)

OTC - ACTIVE INGREDIENT SECTION

Menthol, 4.8 mg

Uses

INDICATIONS & USAGE SECTION

temporarily relieves:

  • cough due to a cold or inhaled irritants
  • occasional minor irritation and pain due to sore throat or sore mouth

Warnings

WARNINGS SECTION

Sore throat warnings:

  • if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.  These may be serious.
  • do not use in children under 6 years of age unless directed by a doctor.

Ask doctor before use if you have

OTC - ASK DOCTOR SECTION

  • persistent chronic cough such as occurs with smoking, asthma, or emphysema
  • cough accompanied by excessive phlegm (mucus)

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache.  These could be signs of a serious condition.
  • sore mouth does not improve in 7 days
  • irritation, pain, or redness persists or worsens

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 6 years and older:  dissolve 2 drops (one at a time) slowly in the mouth.  Repeat every 2 hours as needed or as directed by a doctor
  • children under 6 years: ask a doctor

Other Information

STORAGE AND HANDLING SECTION

  • Phenylketonurics: contains phenylalanine 1 mg per drop
  • excessive use may have a laxative effect
  • store in a dry place
  • product may be useful for diabetics on the advice of a doctor

Exchange information:   2 Drops = FREE Exchange

                                                7 Drops = 1 Fruit

Dietary exchanges based on Exchange Lists for Diabetics

© 2008 American Diabetes Association, American Dietetic Association

Inactive Ingredients

INACTIVE INGREDIENT SECTION

aspartame, color (caramel), extract of a Ricola herb mixture (elder, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme, wild thyme), isomalt, natural flavor, sorbitol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of SF Original Swiss Herb 19 ct.jpgImage of SF Original Swiss Herb 19 ct.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
637119menthol 4.8 MG Oral LozengePSN8
637119menthol 4.8 MG Oral LozengeSCD8

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54305-802-192020-02-10C16284748780-19d75b9d0-17a4-f424-e053-dadaa90a57ceORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS SUGAR FREE
54305-802-242020-02-10C16284748780-19d75b9d0-17a4-f424-e053-dadaa90a57ceORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS SUGAR FREE
54305-802-192020-01-31C16284748780-19d75b9d0-17a4-f424-e053-dadaa90a57ceORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS SUGAR FREE
54305-802-242020-01-31C16284748780-19d75b9d0-17a4-f424-e053-dadaa90a57ceORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS SUGAR FREE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54305-802-19SUGAR FREE ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS19 in 1 BAGLOZENGE198
54305-802-24SUGAR FREE ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS24 in 1 BAGLOZENGE248
54305-802-45SUGAR FREE ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS45 in 1 BAGLOZENGE458

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54305-802SUGAR FREE ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS (MENTHOL) LOZENGE [RICOLA AG]8Current NDC, Legacy NDC, 3 package rows20241207_b790a91c-33be-4bc3-bdeb-eae6f366f085.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3A2
MENTHOLACTIVE MOIETYL7T10EIP3A2
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR12
CARAMELINACTIVE INGREDIENTT9D99G2B1R2
ISOMALTINACTIVE INGREDIENTS870P55O2W2
SORBITOLINACTIVE INGREDIENT506T60A25R2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54305-80254305-802-19, 54305-802-24, 54305-802-45

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
ISOMALTS870P55O2WIACT
SORBITOL506T60A25RIACT
ASPARTAMEZ0H242BBR1IACT
CARAMELT9D99G2B1RIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 116 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SORBITOLSORBITOL506T60A25RTABLET, EXTENDED RELEASE / ORAL428 mgExact identifier — unii+route
72 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RSYRUP / ORAL207 mg/5mlExact identifier — unii+route
24 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCONCENTRATE / ORAL600 mg/1mlExact identifier — unii+route
72 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, DELAYED RELEASE / ORAL0.01 mgExact identifier — unii+route
72 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RLIQUID / ORAL53460 mgExact identifier — unii+route
72 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCAPSULE / ORAL1111 mgExact identifier — unii+route
72 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, EXTENDED RELEASE / ORAL428 mgExact identifier — unii+route
72 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, CHEWABLE / ORAL3555 mgExact identifier — unii+route
72 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RSYRUP / ORAL207 mg/5mlExact identifier — unii+route
24 equally ranked IID candidates
ISOMALTISOMALTS870P55O2WTABLET / ORAL522 mgExact identifier — unii+route
16 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, CHEWABLE / ORAL3555 mgExact identifier — unii+route
72 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION / ORAL29268 mgExact identifier — unii+route
72 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RSOLUTION / ORAL11 mgExact identifier — unii+route
24 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RSOLUTION / ORAL11 mgExact identifier — unii+route
24 equally ranked IID candidates
ISOMALTISOMALTS870P55O2WTROCHE / ORAL1718.71 mgExact identifier — unii+route
16 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RSYRUP / ORAL207 mg/5mlExact identifier — unii+route
24 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION / ORAL29268 mgExact identifier — unii+route
72 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSYRUP / ORAL4370 mg/5mlExact identifier — unii+route
72 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RGUM, CHEWING / ORAL6168 mgExact identifier — unii+route
72 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION / ORAL29268 mgExact identifier — unii+route
72 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RGRANULE, FOR SUSPENSION / ORAL2.5 mg/5mlExact identifier — unii+route
24 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSUSPENSION / ORAL45000 mgExact identifier — unii+route
72 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION, CONCENTRATE / ORAL300 mg/1mlExact identifier — unii+route
72 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RSOLUTION / ORAL11 mgExact identifier — unii+route
24 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RGRANULE, FOR SUSPENSION / ORAL2.5 mg/5mlExact identifier — unii+route
24 equally ranked IID candidates
ISOMALTISOMALTS870P55O2WTABLET, CHEWABLE / ORAL630 mgExact identifier — unii+route
16 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RLIQUID / ORAL5.3 mgExact identifier — unii+route
24 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, CHEWABLE / ORAL3555 mgExact identifier — unii+route
72 equally ranked IID candidates
ISOMALTISOMALTS870P55O2WTABLET, CHEWABLE / ORAL630 mgExact identifier — unii+route
16 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION, CONCENTRATE / ORAL300 mg/1mlExact identifier — unii+route
72 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, FILM COATED / ORAL5 mgExact identifier — unii+route
72 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSUSPENSION / ORAL45000 mgExact identifier — unii+route
72 equally ranked IID candidates
ASPARTAMEASPARTAMEZ0H242BBR1LOZENGE / ORAL136 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCAPSULE / ORAL1111 mgExact identifier — unii+route
72 equally ranked IID candidates
ISOMALTISOMALTS870P55O2WTABLET, CHEWABLE / ORAL630 mgExact identifier — unii+route
16 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RLIQUID / ORAL5.3 mgExact identifier — unii+route
24 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RLIQUID / ORAL53460 mgExact identifier — unii+route
72 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSYRUP / ORAL4370 mg/5mlExact identifier — unii+route
72 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, FILM COATED / ORAL5 mgExact identifier — unii+route
72 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RGUM, CHEWING / ORAL6168 mgExact identifier — unii+route
72 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION / ORAL29268 mgExact identifier — unii+route
72 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RCAPSULE / ORALNAExact identifier — unii+route
24 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET / ORAL337.28 mgExact identifier — unii+route
72 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, FILM COATED / ORAL5 mgExact identifier — unii+route
72 equally ranked IID candidates
ISOMALTISOMALTS870P55O2WTROCHE / ORAL1718.71 mgExact identifier — unii+route
16 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RELIXIR / ORAL833.3 mgExact identifier — unii+route
72 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, DELAYED RELEASE / ORAL0.01 mgExact identifier — unii+route
72 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RGUM, CHEWING / ORAL6168 mgExact identifier — unii+route
72 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, FILM COATED / ORAL5 mgExact identifier — unii+route
72 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RLIQUID / ORAL53460 mgExact identifier — unii+route
72 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, DELAYED RELEASE / ORAL0.01 mgExact identifier — unii+route
72 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, ORALLY DISINTEGRATING / ORAL7 mgExact identifier — unii+route
72 equally ranked IID candidates
ISOMALTISOMALTS870P55O2WCAPSULE / ORAL158 mgExact identifier — unii+route
16 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RSYRUP / ORAL207 mg/5mlExact identifier — unii+route
24 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPOWDER / ORAL36000 mgExact identifier — unii+route
72 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSUSPENSION / ORAL45000 mgExact identifier — unii+route
72 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCONCENTRATE / ORAL600 mg/1mlExact identifier — unii+route
72 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, COATED / ORAL12.96 mgExact identifier — unii+route
72 equally ranked IID candidates
ISOMALTISOMALTS870P55O2WTROCHE / ORAL1718.71 mgExact identifier — unii+route
16 equally ranked IID candidates
ISOMALTISOMALTS870P55O2WTABLET / ORAL522 mgExact identifier — unii+route
16 equally ranked IID candidates

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUGAR FREE ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPSMENTHOLRicola Agb790a91c-33be-4bc3-bdeb-eae6f366f0852024-12-05WarningsExact identifier
ndc (package): 54305-802-24
ndc (package): 54305-802-19
ndc (package): 54305-802-45
ndc (product): 54305-802
ndc11 (package): 54305080219
ndc11 (package): 54305080224
ndc11 (package): 54305080245
spl id: 2f7f3ce7-2f0b-4982-9aa0-f858d0e64179
spl set id: b790a91c-33be-4bc3-bdeb-eae6f366f085

Reported adverse events (FAERS/openFDA)#

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