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 120 of 290 · 5,785 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.009bef3c-e8ac-46be-b564-a2556adf00812025-10-31Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Potassium Chloride in Lactated Ringers and DextrosePOTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, AND DEXTROSE MONOHYDRATEICU Medical Inc.237b39fa-916e-4a54-99c8-4ae9ad54f0562025-10-30Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF45 BROAD SPECTRUMAVOBENZONE, HOMOSALATE, OCTISALATESEORIN COMPANY Co., Ltd.4260e410-d2d5-71b4-e063-6294a90a05b82025-10-30WarningsExact identifier
unii: G63QQF2NOX
ADVANCED REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEWALGREEN COMPANY5faf6229-b0fd-58df-e053-2a91aa0ab3bb2025-10-30WarningsExact identifier
unii: 92RU3N3Y1O
WEIGHTLESS PROTECTION SPF 30OCTINOXATE, ZINC OXIDE, OCTISALATEBotanical Science Technologiesde9a97b8-6633-4d71-e053-2995a90a5e8f2025-10-30WarningsExact identifier
unii: 4Y5P7MUD51
Normosol-R and DextroseDEXTROSE, SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDEICU Medical Inc.ead1fca3-eff4-478f-8a8f-67510f80151a2025-10-30Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Avinichi Noni Sol Shield Cream SPF 30OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONEInnovation Brands Inc.9e534e32-efea-4dcf-adc1-18de3847ac042025-10-30WarningsExact identifier
unii: G63QQF2NOX
unii: 4Y5P7MUD51
Normosol-RSODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDEICU Medical Inc.0e089a44-0cee-4804-8f6f-8508508ddb5c2025-10-30Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Normosol-RSODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDEICU Medical Inc.189b8ac6-e346-454f-b501-7645590ca4f82025-10-29Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
MOOYAM Dark Skin SunscreenSUNSCREENGuangdong Bisutang Biotechnology Co., LTD4246e9f1-1c51-d888-e063-6394a90abda02025-10-29WarningsExact identifier
unii: 4Y5P7MUD51
Extra Strength Gas ReliefSIMETHICONESAFEWAYc8946bd2-6351-40e4-a139-d8214889bb4e2025-10-29WarningsExact identifier
unii: 92RU3N3Y1O
Extra Strength Gas ReliefSIMETHICONE ANTIGASSAFEWAYcbbd43eb-1155-4e0d-bed4-32343f34b5032025-10-29WarningsExact identifier
unii: 92RU3N3Y1O
Zinc Cold TherapyZINC GLUCONATEBETTER LIVING BRANDS LLC4ad45191-a1ce-42b3-86f8-b2d212804f0a2025-10-29WarningsExact identifier
unii: U6WSN5SQ1Z
Zinc Cold TherapyZINC GLUCONATEBETTER LIVING BRANDS LLC4bd136d8-b001-4a16-9429-4a7f0921acb82025-10-29WarningsExact identifier
unii: U6WSN5SQ1Z
GlycerinGLYCERINChain Drug Marketing Association Inc.424d91f0-ecf9-6d9b-e063-6394a90a80062025-10-29WarningsExact identifier
unii: PDC6A3C0OX
Cold and Cough 4 KidsONION, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, AND GOLDENSEALHyland's Inc.e06599ca-fc94-4b2c-829e-f3d4ec866ed62025-10-29WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDECardinal Health 107, LLC97007188-43fe-416c-a87b-6ccc4d9ae2ec2025-10-29Adverse reactionsExact identifier
unii: 451W47IQ8X
hemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMPublix Super Markets Inc354a640c-bc7e-45c8-9df0-8b5b01767f5c2025-10-29WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Potassium Chloride in Lactated Ringers and DextroseDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEBaxter Healthcare Corporation05f326e6-10e4-4ceb-8a23-f53c592f00b82025-10-29Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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