FDA.reportPublic FDA data

Baby Nighttime Oral Pain Relief

Manufacturer
Hyland' Inc.
Effective date
2025-03-17
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
full-release
Hydrated at
2026-06-01 02:32:38

Label at a glance#

ProductBaby Nighttime Oral Pain Relief
Active ingredientOYSTER SHELL CALCIUM CARBONATE, CRUDE, TRIBASIC CALCIUM PHOSPHATE, MATRICARIA CHAMOMILLA, SILICON DIOXIDE, ARNICA MONTANA, FERROSOFERRIC PHOSPHATE, ARABICA COFFEE BEAN, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE
Label structure8 sections

Indications and uses

■ Helps temporarily relieve symptoms of oral pain or discomfort in children, including: ■ teething ■ gum sensitivity ■ swelling or soreness of gums ■ irritability ■ occasional sleeplessness

Dosage and administration

■ Use as directed. Children under 6 months At onset of symptoms, dissolve 2 tablets on tongue every hour up to 4 hours as needed. If symptoms persist, 2 tablets every 4 hours during the night until relieved. Children 6 months to under 3 years At onset of symptoms, dissolve 3 tablets on tongue every hour up to 4 hours as needed. If symptoms persist, 3 tablets every 4 hours during the night until relieved

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

OTC - ACTIVE INGREDIENT SECTION

Active ingredientsPurpose
Arnica Montana 30X HPUSsore, sensitive or swelling gums
Calcarea Carbonica 12X HPUSteething, sore, sensitive or swelling gums
Calcarea Phosphorica 12X HPUSteething, sensitive, swelling gums, oral pain
Chamomilla 12X HPUSsore, sensitive or swelling gums
Coffea Cruda 6X HPUSoral pain, irritability
Ferrum Phosphoricum 12X HPUSoral discomfort, swelling gums
Magnesia Phosphorica 12X HPUSoral pain, occasional sleeplessness
Silicea 12X HPUSoral pain at night, occasional sleeplessness

"HPUS" is the Homeopathic Pharmacopoeia of the United States.

Uses

INDICATIONS & USAGE SECTION

■ Helps temporarily relieve symptoms of oral pain or discomfort in children, including:
■ teething ■ gum sensitivity ■ swelling or soreness of gums
■ irritability ■ occasional sleeplessness

Warnings

WARNINGS SECTION

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ symptoms persist for more than 72 hours or worsen.

■ swelling increases; nasal congestion, rash or fever is present or develops.

■ irritation, pain or redness persists or worsens.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

■ Use as directed.

Children under
6 months 		At onset of symptoms, dissolve 2 tablets on tongue every hour up to 4 hours as needed. If symptoms persist,
2 tablets every 4 hours during the night until relieved.
Children 6 months
to under 3 years 		At onset of symptoms, dissolve 3 tablets on tongue every hour up to 4 hours as needed. If symptoms persist,
3 tablets every 4 hours during the night until relieved

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acacia Gum, Lactose.

OTC - PURPOSE SECTION

Helps temporarily relieve symptoms of oral pain or discomfort in children, including: teething, gum sensitivity, swelling or soreness of gums, irritability, occasional sleeplessness.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hyland's

NATURALS

•baby•

Oral Pain

Relief*

NIGHTTIME

NO BENZOCAINE,

DYES or PARABENS

Sleeplessness

Teething Pain

Oral Discomfort

Irritability

Swelling

0+ Months

125

QUICK-DISSOLVING TABLETS

HOMEOPATHIC

BNPR Carton ArtBNPR Carton Art

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-3324-1Baby Nighttime Oral Pain Relief1 g in 1 BOTTLE, PLASTICTABLET113
54973-3324-1Baby Nighttime Oral Pain Relief1 in 1 CARTONTABLET113
54973-3324-4Baby Nighttime Oral Pain Relief6 g in 1 PACKETTABLET613

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-3324BABY NIGHTTIME ORAL PAIN RELIEF (ARNICA MONTANA, TRIBASIC CALCIUM PHOSPHATE, MATRICARIA CHAMOMILLA, SILICON DIOXIDE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, FERROSOFERRIC PHOSPHATE, ARABICA COFFEE BEAN AND OYSTER SHELL CALCIUM CARBONATE, CRUDE) TABLET [HYLAND' INC.]13Current NDC, Legacy NDC, 3 package rows20250321_58ef86b7-5b38-1591-e053-2991aa0aa53e.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54973-332454973-3324-1, 54973-3324-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
ACACIA5C5403N26OIACT
OYSTER SHELL CALCIUM CARBONATE, CRUDE2E32821G6IACTIB
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28ACTIB
MATRICARIA CHAMOMILLAG0R4UBI2ZZACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
ARNICA MONTANAO80TY208ZWACTIB
FERROSOFERRIC PHOSPHATE91GQH8I5F7ACTIB
ARABICA COFFEE BEAN3SW678MX72ACTIB
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEHF539G9L3QACTIB

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
Baby Nighttime Oral Pain ReliefARNICA MONTANA, TRIBASIC CALCIUM PHOSPHATE, MATRICARIA CHAMOMILLA, SILICON DIOXIDE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, FERROSOFERRIC PHOSPHATE, ARABICA COFFEE BEAN AND OYSTER SHELL CALCIUM CARBONATE, CRUDEHyland' Inc.58ef86b7-5b38-1591-e053-2991aa0aa53e2025-03-17WarningsExact identifier
ndc (package): 54973-3324-1
ndc (package): 54973-3324-4
ndc (product): 54973-3324
ndc11 (package): 54973332404
ndc11 (package): 54973332401
spl id: 308ccf50-c319-2cd0-e063-6394a90aa99e
spl set id: 58ef86b7-5b38-1591-e053-2991aa0aa53e

Reported adverse events (FAERS/openFDA)#

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