FDA.reportPublic FDA data

CHAMOMILLA 30C - 3-Pack

Manufacturer
SEVENE USA
Effective date
2025-05-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:33:33

Label at a glance#

ProductCHAMOMILLA 30C - 3-Pack
Active ingredientMATRICARIA RECUTITA
Label structure12 sections

Dosage and administration

(adults/children) Dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a physician.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

HOMEOPATHIC DILUTION OF CHAMOMILLA 30c

TRADITIONALLY USED FOR

INDICATIONS & USAGE SECTION

Teething pain & irritability - restlessness*

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

(adults/children) Dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a physician.

USE

OTC - PURPOSE SECTION

Condition listed above or as directed by a physician.

WARNINGS

WARNINGS SECTION

Stop use and ask a physician if symptoms persist for more than 3 days or worsen.

PREGNANCY OR BREAST FEEDING

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.Keep out of reach of children.

OTHER INFORMATION

OTHER SAFETY INFORMATION

Store at room temperature.

DO NOT USE

OTC - DO NOT USE SECTION

Do not use if pellet-dispenser seal is broken.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Sucrose.

QUESTIONS?

OTC - QUESTIONS SECTION

info@ollois.com * www.ollois.com * MADE IN FRANCE. NOT REVIEWED BY THE FDA AND NOT GUARANTEED TO BE EFFECTIVE. THIS HOMEOPATHIC DILUTION MAY NOT BE SUSEPTIBLE TO SCIENTIFIC MEASUREMENT.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CHAMOMILLA 30C 3P P1CHAMOMILLA 30C 3P P1CHAMOMILLA 30C 3P P2CHAMOMILLA 30C 3P P2CHAMOMILLA 30C 3P P3CHAMOMILLA 30C 3P P3ETUI CHAMOMILLA 30C 3P P1ETUI CHAMOMILLA 30C 3P P1ETUI CHAMOMILLA 30C 3P P2ETUI CHAMOMILLA 30C 3P P2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76472-5002-1CHAMOMILLA 30C - 3-Pack80 in 1 CYLINDERPELLET802
76472-5002-2CHAMOMILLA 30C - 3-Pack3 in 1 BOXPELLET32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76472-5002CHAMOMILLA 30C - 3-PACK (CHAMOMILLA) PELLET [SEVENE USA]2Current NDC, 2 package rows20250516_31e1cdc7-b32f-d36c-e063-6294a90a27c0.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76472-500276472-5002-1, 76472-5002-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUCROSEC151H8M554IACT
MATRICARIA RECUTITAG0R4UBI2ZZACTIB

Source Document#

Source XML

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
CHAMOMILLA 30C - 3-PackCHAMOMILLASEVENE USA31e1cdc7-b32f-d36c-e063-6294a90a27c02025-05-15WarningsExact identifier
ndc (package): 76472-5002-2
ndc (package): 76472-5002-1
ndc (product): 76472-5002
ndc11 (package): 76472500202
ndc11 (package): 76472500201
spl id: 352e4c3c-0454-33b2-e063-6294a90a65ee
spl set id: 31e1cdc7-b32f-d36c-e063-6294a90a27c0

Reported adverse events (FAERS/openFDA)#

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