FDA.reportPublic FDA data

NDC 69378-001 - Soothe and Hydrate Starter Set

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
69378-001
Package NDCs from labels
69378-001-16
Manufacturer
Acheson & Acheson Ltd.
Effective date
2022-12-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Soothe & Hydrate Starter SetAcheson & Acheson Ltd.2022-12-14HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
69378-001-152020-02-12070687bf-9823-4f5c-ad4d-72cde86d8209
69378-001-502020-02-12070687bf-9823-4f5c-ad4d-72cde86d8209
69378-001-512020-02-12070687bf-9823-4f5c-ad4d-72cde86d8209
69378-001-152020-01-31070687bf-9823-4f5c-ad4d-72cde86d8209
69378-001-502020-01-31070687bf-9823-4f5c-ad4d-72cde86d8209
69378-001-512020-01-31070687bf-9823-4f5c-ad4d-72cde86d8209

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69378-001-16Soothe and Hydrate Starter Set15 g in 1 TUBECREAM15 g5 mg in 1g3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69378-001SOOTHE AND HYDRATE STARTER SET (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) KIT [ACHESON & ACHESON LTD.]3Unmatched20221217_d78476ae-4a90-2d19-e053-2a95a90af8de.zip

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 121 of 290 · 5,785 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lactated Ringers and DextroseSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE AND DEXTROSE MONOHYDRATEBaxter Healthcare Corporation6acc9f96-7088-45a7-b48f-1a861e3467ab2025-10-29Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Lactated RingersSODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM LACTATE AND CALCIUM CHLORIDEBaxter Healthcare Companydad7735c-709b-40ea-ab7a-15577e24a9662025-10-29Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
meijer EXTRA STRENGTH Gas ReliefSIMETHICONEMeijer, Inc3e83bb0f-d909-08c3-e063-6294a90ae1382025-10-29WarningsExact identifier
unii: 92RU3N3Y1O
WALMART SALINESALINE NASAL (SODIUM CHLORIDE)WALMART STORES INC06906744-49a5-4bab-8539-af2d235df9e82025-10-28WarningsExact identifier
unii: 451W47IQ8X
SalineNASALPUBLIX SUPER MARKETS, INC19841567-9511-43d6-ba4e-d1e1bd3481a42025-10-28WarningsExact identifier
unii: 451W47IQ8X
Publix Infants Dye Free Gas ReliefSIMETHICONEPUBLIX SUPER MARKETS, INC2fe74800-a1f6-4774-9976-d6767ba34b492025-10-28WarningsExact identifier
unii: 92RU3N3Y1O
Remedy NutrashieldDIMETHICONEMedline Industries, LPed8a08a7-594c-46e2-b70f-b75b2960141f2025-10-28WarningsExact identifier
unii: 92RU3N3Y1O
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
LACRIFRESH HYDRAPFGLYCERIN, POVIDONEAVIZOR, S.A.41bbd23e-0ec8-eb18-e063-6294a90a46d12025-10-27WarningsExact identifier
unii: PDC6A3C0OX
LACRIFRESH HYDRAMAXPFGLYCERIN, POVIDONEAVIZOR, S.A.41be1604-89b4-7ec3-e063-6294a90a33312025-10-27WarningsExact identifier
unii: PDC6A3C0OX
Extra Strength Gas ReliefSIMETHICONEWal-Mart Stores,Inc.,e6087f04-20bf-402c-892b-e64f778b01442025-10-27WarningsExact identifier
unii: 92RU3N3Y1O
Zinc cold Remedy Non DrowsyZINCUM GLUCONICUMWALMART STORES INC84c511bb-46c4-4565-a4ff-ba5d64bbc8c42025-10-27WarningsExact identifier
unii: U6WSN5SQ1Z
ZincZINC GLUCONATEWal-Mart Stores,Inc.,ef4d82f6-2b77-41cd-9f4a-86ca9906a00d2025-10-27WarningsExact identifier
unii: U6WSN5SQ1Z
Boudreauxs Butt BarrierDIMETHICONEC.B. Fleet Company, Inc.06a5af4d-40dd-42a4-8368-4d6a772d1b3a2025-10-27WarningsExact identifier
unii: 92RU3N3Y1O
InfantsSIMETHICONERUGBY LABORATORIESc6fa71bc-de48-47f4-80c4-7d92643d26642025-10-25WarningsExact identifier
unii: 92RU3N3Y1O
Neutrogena Ultra Sheer Face Sunscreen SPF 60AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLC23670a30-6619-0651-e063-6394a90af9782025-10-24WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
GlycerinGLYCERINDSC Laboratories Inc.5e97aa5b-62e2-0664-e053-2a91aa0ac3412025-10-24WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINH E B3d03ce42-e671-6d76-e054-00144ff8d46c2025-10-24WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINChain Drug Consortium LLC022dd494-cb3c-4fa7-be99-4c38fabdc6122025-10-24WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINDSC Laboratories Inc.5e97c4d2-e41d-5bb6-e053-2a91aa0a31632025-10-24WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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