Baby Oral Pain Relief

Manufacturer: Hyland' Inc. | Hyland's Inc.
Effective date: 2025-02-06
Label type: HUMAN OTC DRUG LABEL
Version: 15
Source: full-release
Hydrated at: 2026-06-01 02:31:47

Label at a glance#

ProductBaby Oral Pain Relief

Active ingredientOYSTER SHELL CALCIUM CARBONATE, CRUDE, TRIBASIC CALCIUM PHOSPHATE, ARABICA COFFEE BEAN, ARNICA MONTANA, MATRICARIA CHAMOMILLA, FERRUM PHOSPHORICUM

Label structure9 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

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

Contacts and useful links#

Websitewww.hylands.com

www.hylands.com

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

OTC - ACTIVE INGREDIENT SECTION

Active ingredients	Purpose
Arnica Montana 30X HPUS	sore, sensitive or swelling gums
Calcarea Carbonica 12X HPUS	teething, sore, sensitive or swelling gums
Calcarea Phosphorica 12X HPUS	teething, sensitive, swelling gums, oral pain
Chamomilla 12X HPUS	sore, sensitive or swelling gums
Coffea Cruda 6X HPUS	oral pain, irritability
Ferrum Phosphoricum 12X HPUS	oral discomfort, swelling gums

"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

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acacia Gum, Lactose.

Questions?

OTC - QUESTIONS SECTION

www.hylands.com or care@hylands.com

OTC - PURPOSE SECTION

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

Indications and Usage

RECENT MAJOR CHANGES SECTION

Uses*

Removed *

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hyland's

NATURALS™

•baby•

Oral Pain

Relief*

DAYTIME

NO BENZOCAINE,

DYES or PARABENS

Teething Pain
Oral Discomfort
Irritability
Swelling

0+ MONTHS

125

^{QUICK-DISSOLVING TABLETS}

HOMEOPATHIC

BOPR0000T125CTNH1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
efd58dcf-540a-4531-8766-e713129ca6f2	Product name	1	20250307
4b7700e3-6e0e-45e5-9d22-6f754d61386e	Product name	2	20250304
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
54973-3315-1	Baby Oral Pain Relief	1 in 1 CARTON	TABLET	1	15
54973-3315-1	Baby Oral Pain Relief	125 g in 1 BOTTLE, PLASTIC	TABLET	125	15
54973-3315-3	Baby Oral Pain Relief	6 g in 1 PACKET	TABLET	6	15
54973-3315-7	Baby Oral Pain Relief	1 in 1 CARTON	TABLET	1	15
54973-3315-7	Baby Oral Pain Relief	80 g in 1 BOTTLE, PLASTIC	TABLET	80	15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54973-3315	BABY ORAL PAIN RELIEF (OYSTER SHELL CALCIUM CARBONATE, CRUDE, TRIBASIC CALCIUM PHOSPHATE, ARABICA COFFEE BEAN, ARNICA MONTANA, FERRUM PHOSPHORICUM AND MATRICARIA CHAMOMILLA) TABLET [HYLAND' INC.]	15	Current NDC, Legacy NDC, 5 package rows	20250209_5904f126-e8f0-a892-e053-2991aa0aef0f.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

Baby Oral Pain Relief
oyster shell calcium carbonate, crude, tribasic calcium phosphate, arabica coffee bean, arnica montana, ferrum phosphoricum and matricaria chamomilla
ACACIA
LACTOSE MONOHYDRATE
ANHYDROUS LACTOSE
OYSTER SHELL CALCIUM CARBONATE, CRUDE
TRIBASIC CALCIUM PHOSPHATE
PHOSPHATE ION
ARABICA COFFEE BEAN
ARNICA MONTANA
MATRICARIA CHAMOMILLA
FERRUM PHOSPHORICUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54973-3315	54973-3315-1, 54973-3315-3, 54973-3315-7

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ACACIA	5C5403N26O	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
OYSTER SHELL CALCIUM CARBONATE, CRUDE	2E32821G6I	ACTIB
TRIBASIC CALCIUM PHOSPHATE	91D9GV0Z28	ACTIB
ARABICA COFFEE BEAN	3SW678MX72	ACTIB
ARNICA MONTANA	O80TY208ZW	ACTIB
MATRICARIA CHAMOMILLA	G0R4UBI2ZZ	ACTIB
FERRUM PHOSPHORICUM	91GQH8I5F7	ACTIB

Source Document#

Source XML · Source PDF

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Baby Oral Pain Relief	OYSTER SHELL CALCIUM CARBONATE, CRUDE, TRIBASIC CALCIUM PHOSPHATE, ARABICA COFFEE BEAN, ARNICA MONTANA, FERRUM PHOSPHORICUM AND MATRICARIA CHAMOMILLA	Hyland' Inc.	5904f126-e8f0-a892-e053-2991aa0aef0f	2025-02-06	Warnings	Exact identifier ndc (package): 54973-3315-1 ndc (package): 54973-3315-3 ndc (package): 54973-3315-7 ndc (product): 54973-3315 ndc11 (package): 54973331507 ndc11 (package): 54973331503 ndc11 (package): 54973331501 spl id: 2d83ba02-987c-b74b-e063-6294a90a6dc0 spl set id: 5904f126-e8f0-a892-e053-2991aa0aef0f

Reported adverse events (FAERS/openFDA)#

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