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 51 of 297 · 5,938 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zicam Cold Remedy Medicated Fruit Drops - Assorted FruitZINC ACETATE ANHYDROUS AND ZINC GLUCONATEChurch & Dwight Co., Inc.ce2daf65-37b9-11e1-e053-2a95a90a6f0c2026-03-09WarningsExact identifier
unii: U6WSN5SQ1Z
Zicam Cold Remedy Medicated Fruit Drops - ElderberryZINC ACETATE ANHYDROUS, ZINC GLUCONATE, AND SAMBUCUS NIGRA FLOWERING TOPChurch & Dwight Co., Inc.ce2e9d9b-b49e-ab61-e053-2a95a90a06422026-03-09WarningsExact identifier
unii: U6WSN5SQ1Z
Civant 50 Sunscreen Broad Spectrum SPF 50OCTOCRYLENE, ZINC OXIDECivant LLCe23622b8-49dd-45b9-8c51-1a83181cc7bd2026-03-09WarningsExact identifier
unii: 5A68WGF6WM
HydroScreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEMETHODIQ INC.4c9d5dfd-d790-fffc-e063-6294a90a4d302026-03-09WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
EADEM SUNSUEDE DAILY SUNSCREEN AND BLURRING PRIMER SPF50 PLUSAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEEADEM, Inc.4ca05e2f-f0c5-821c-e063-6294a90a90b82026-03-09WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
Sodium ChlorideSODIUM CHLORIDEHospira, Inc.018a8807-1331-41c3-4889-c7ec502a90432026-03-09Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
FleetGLYCERINC.B. Fleet Company, Inc.31778652-e60e-4098-8e90-3e4f56b5800c2026-03-06WarningsExact identifier
unii: PDC6A3C0OX
STYE EYE RELIEF SERUMVITAMIN E, LYSINEGuangzhou Mizi Biotechnology Co., LTD.4c592b9b-53ad-4fe6-e063-6294a90ae9792026-03-06WarningsExact identifier
unii: YSE9PPT4TH
GlycerinGLYCERINBeijing Jingfeng Pharmaceutical (Shandong) Co., Ltd4c6094b7-c1ef-26a3-e063-6394a90af4cc2026-03-06WarningsExact identifier
unii: PDC6A3C0OX
COOLA SunBlur Primer SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA LLC4c6439e8-abda-663a-e063-6394a90ac43b2026-03-06WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
COOLA SunBlur Makeup Mist SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA LLC4c666a82-293e-06df-e063-6294a90ad5512026-03-06WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
No 7 Restore and Renew Multi Action Fragrance Free Day Cream SPF 25AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS4d6d1fda-da78-62ed-e063-6294a90ac1052026-03-06WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4Y5P7MUD51
Artificial TearsGLYCERINPreferred Pharmaceuticals Inc.dd646c72-8f47-43c6-a734-db0dcc8cd4d12026-03-06WarningsExact identifier
unii: PDC6A3C0OX
Headache and Migraine ReliefBELLADONNA, BRYONIA, CAPSICUM ANNUUM, GELSEMIUM, GLONOINUM, IGNATIA AMARA, KALI BICHROMICUM, KALI CARBONICUM, LYCOPODIUM, NATRUM MURIATICUM, NICCOLUM METALLICUM, NUX VOMICA, SANGUINARIA, SECALE CORNUTUM, SPIGELIA ANTH AND SULPHUR.King Bio Inc.efbfd58c-f3a6-4734-a37f-9f58fded990a2026-03-06WarningsExact identifier
unii: 451W47IQ8X
Palio Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATESole Palio LLC071d5113-8fe8-44bb-8322-542eafc2800a2026-03-05WarningsExact identifier
unii: G63QQF2NOX
Olay Age Defying Classic Broad Spectrum SPF 15OCTINOXATE AND ZINC OXIDEThe Procter & Gamble Manufacturing Company4c49dbf1-d1fe-ad4a-e063-6394a90af1512026-03-05WarningsExact identifier
unii: 4Y5P7MUD51
SPF 70 Kids SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDerma Care Research Labs, LLC0aadc378-dc34-9a37-e063-6294a90ad49e2026-03-05WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
Dry Eye Relief Sterile Lubricant Eye DropsGLYCERINSimilasan Corporation4c4cce1c-392e-354d-e063-6294a90a0ca32026-03-05WarningsExact identifier
unii: PDC6A3C0OX
cle de peau BEAUTE RADIANT FLUID FOUNDATION NATURAL B50OCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION4490f968-46b6-44d2-af2d-5130b52c88612026-03-05WarningsExact identifier
unii: 4Y5P7MUD51

Reported adverse events (FAERS/openFDA)#

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