Baby Oral Pain Relief

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Baby Oral Pain Relief
Generic name: OYSTER SHELL CALCIUM CARBONATE, CRUDE, TRIBASIC CALCIUM PHOSPHATE, ARABICA COFFEE BEAN, ARNICA MONTANA, FERRUM PHOSPHORICUM AND MATRICARIA CHAMOMILLA
Manufacturer: Hyland' Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 5904f126-e8f0-a892-e053-2991aa0aef0f
SPL ID: 2d83ba02-987c-b74b-e063-6294a90a6dc0
Version: 15
Effective date: 2025-02-06
Source export date: 2026-09-28
Source partition: 2
Source file: https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:15:20

Harmonized routes table
Harmonized routes
ORAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 18 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
brand name		Baby Oral Pain Relief	openfda.brand_name
generic name		OYSTER SHELL CALCIUM CARBONATE, CRUDE, TRIBASIC CALCIUM PHOSPHATE, ARABICA COFFEE BEAN, ARNICA MONTANA, FERRUM PHOSPHORICUM AND MATRICARIA CHAMOMILLA	openfda.generic_name
manufacturer name		Hyland' Inc.	openfda.manufacturer_name
ndc	package	54973-3315-1	openfda.package_ndc
ndc	package	54973-3315-3	openfda.package_ndc
ndc	package	54973-3315-7	openfda.package_ndc
ndc	product	54973-3315	openfda.product_ndc
ndc11	package	54973331507	derived:openfda.package_ndc
ndc11	package	54973331503	derived:openfda.package_ndc
ndc11	package	54973331501	derived:openfda.package_ndc
spl id		2d83ba02-987c-b74b-e063-6294a90a6dc0	id
spl set id		5904f126-e8f0-a892-e053-2991aa0aef0f	set_id
unii		3SW678MX72	openfda.unii
unii		O80TY208ZW	openfda.unii
unii		91D9GV0Z28	openfda.unii
unii		2E32821G6I	openfda.unii
unii		91GQH8I5F7	openfda.unii
unii		G0R4UBI2ZZ	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Stop use and ask a doctor if ■ 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

Reported adverse events (FAERS/openFDA)#

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