AquaSoothe

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: AquaSoothe
Generic name: AQUASOOTHE
Manufacturer: Dynarex Corporation
Product type: HUMAN OTC DRUG
SPL set ID: 45878c3c-d05d-984c-e063-6294a90a4661
SPL ID: 45878c3c-d05e-984c-e063-6294a90a4661
Version: 1
Effective date: 2025-12-09
Source export date: 2026-09-28
Source partition: 11
Source file: https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:17:54

Harmonized routes table
Harmonized routes
TOPICAL

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 · 21 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M016	openfda.application_number
brand name		AquaSoothe	openfda.brand_name
generic name		AQUASOOTHE	openfda.generic_name
manufacturer name		Dynarex Corporation	openfda.manufacturer_name
ndc	package	67777-555-01	openfda.package_ndc
ndc	package	67777-555-04	openfda.package_ndc
ndc	package	67777-555-03	openfda.package_ndc
ndc	package	67777-555-06	openfda.package_ndc
ndc	package	67777-555-05	openfda.package_ndc
ndc	package	67777-555-02	openfda.package_ndc
ndc	product	67777-555	openfda.product_ndc
ndc11	package	67777055504	derived:openfda.package_ndc
ndc11	package	67777055503	derived:openfda.package_ndc
ndc11	package	67777055502	derived:openfda.package_ndc
ndc11	package	67777055501	derived:openfda.package_ndc
ndc11	package	67777055505	derived:openfda.package_ndc
ndc11	package	67777055506	derived:openfda.package_ndc
rxcui		725145	openfda.rxcui
spl id		45878c3c-d05e-984c-e063-6294a90a4661	id
spl set id		45878c3c-d05d-984c-e063-6294a90a4661	set_id
unii		4T6H12BN9U	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 For external use only Do not get into eyes Stop use and ask a doctor if • Condition worsens • Symptoms last more than 7 days or clear up and occur again with a few days Do not use • On deep or puncture wounds • Animal bites • Serious burns Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Reported adverse events (FAERS/openFDA)#

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