FDA.reportPublic FDA data

NDC 0904-0428-51 - Doxycycline Hyclate

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
0904-0428
Requested NDC
0904-0428-51
Package NDCs from labels
0904-0428-04, 0904-0428-06, 0904-0428-51
Manufacturer
Major Pharmaceuticals
Effective date
2025-12-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Doxycycline Hyclate - Major PharmaceuticalsMajor Pharmaceuticals2025-12-23HUMAN PRESCRIPTION DRUG LABEL
DOXYCYCLINE HYCLATE CAPSULES, USPBlenheim Pharmacal, Inc.2015-04-10HUMAN PRESCRIPTION DRUG LABEL
Doxycycline Hyclate - State of Florida DOH Central PharmacyState of Florida DOH Central Pharmacy2013-09-10HUMAN PRESCRIPTION DRUG LABEL
DOXYCYCLINE HYCLATE CAPSULES, USPC.O. Truxton, Inc. | West-ward Pharmaceutical Corp | Apotheca Inc.2013-06-12HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-11Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-0428-04Doxycycline Hyclate30 in 1 CARTONCAPSULE3017
0904-0428-04Doxycycline Hyclate1 in 1 BLISTER PACKCAPSULE117
0904-0428-06Doxycycline Hyclate1 in 1 BLISTER PACKCAPSULE117
0904-0428-06Doxycycline Hyclate50 in 1 CARTONCAPSULE5017

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-0428DOXYCYCLINE HYCLATE CAPSULE [MAJOR PHARMACEUTICALS]15Current NDC, Legacy NDC, 4 package rows20250226_c4aae81f-0219-450f-aa60-953964f74172.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-0428-04EA - Each0904-04286c7f92e3-d467-4c90-a6be-7ff318483e8412019-09-05
0904-0428-06EA - Each0904-0428e0fcfd55-5f82-4111-9d83-b6af581713b012019-09-05
0904-0428-40EA - Each0904-0428a2a8d5a4-d144-40ed-8ca7-a06b7544026d12013-02-11
0904-0428-51EA - Each0904-04280cd4b802-92cc-4137-aa9e-99abc38cb23112013-02-11
0904-0428-61EA - Each0904-0428d75cca9d-d64d-4a75-98d7-08564bb7e4ce12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXYCYCLINE HYCLATEACTIVE INGREDIENT19XTS3T51UDOXYCYCLINE HYCLATE CAPSULE [MAJOR PHARMACEUTICALS]8
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXYCYCLINE HYCLATE CAPSULE [MAJOR PHARMACEUTICALS]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE HYCLATE CAPSULE [MAJOR PHARMACEUTICALS]8
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDOXYCYCLINE HYCLATE CAPSULE [MAJOR PHARMACEUTICALS]8
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDOXYCYCLINE HYCLATE CAPSULE [MAJOR PHARMACEUTICALS]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXYCYCLINE HYCLATE CAPSULE [MAJOR PHARMACEUTICALS]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DOXYCYCLINE HYCLATE CAPSULE [MAJOR PHARMACEUTICALS]8
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDOXYCYCLINE HYCLATE CAPSULE [MAJOR PHARMACEUTICALS]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE HYCLATE CAPSULE [MAJOR PHARMACEUTICALS]8
DOXYCYCLINE HYCLATEACTIVE INGREDIENT19XTS3T51UDOXYCYCLINE HYCLATE CAPSULE [BLENHEIM PHARMACAL, INC.]2
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXYCYCLINE HYCLATE CAPSULE [BLENHEIM PHARMACAL, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE HYCLATE CAPSULE [BLENHEIM PHARMACAL, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDOXYCYCLINE HYCLATE CAPSULE [BLENHEIM PHARMACAL, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDOXYCYCLINE HYCLATE CAPSULE [BLENHEIM PHARMACAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXYCYCLINE HYCLATE CAPSULE [BLENHEIM PHARMACAL, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DOXYCYCLINE HYCLATE CAPSULE [BLENHEIM PHARMACAL, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDOXYCYCLINE HYCLATE CAPSULE [BLENHEIM PHARMACAL, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE HYCLATE CAPSULE [BLENHEIM PHARMACAL, INC.]2
DOXYCYCLINE HYCLATEACTIVE INGREDIENT19XTS3T51UDOXYCYCLINE HYCLATE CAPSULE [C.O. TRUXTON, INC.]1
DOXYCYCLINE HYCLATEACTIVE INGREDIENT19XTS3T51UDOXYCYCLINE HYCLATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXYCYCLINE HYCLATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXYCYCLINE HYCLATE CAPSULE [C.O. TRUXTON, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE HYCLATE CAPSULE [C.O. TRUXTON, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE HYCLATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDOXYCYCLINE HYCLATE CAPSULE [C.O. TRUXTON, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDOXYCYCLINE HYCLATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDOXYCYCLINE HYCLATE CAPSULE [C.O. TRUXTON, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDOXYCYCLINE HYCLATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXYCYCLINE HYCLATE CAPSULE [C.O. TRUXTON, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXYCYCLINE HYCLATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DOXYCYCLINE HYCLATE CAPSULE [C.O. TRUXTON, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DOXYCYCLINE HYCLATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDOXYCYCLINE HYCLATE CAPSULE [C.O. TRUXTON, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDOXYCYCLINE HYCLATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE HYCLATE CAPSULE [C.O. TRUXTON, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE HYCLATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

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 1 of 278 · 5,543 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HERA SILKYSTAY FOUNDATION 37W1TITANIUM DIOXIDEAmorepacific Corporation5f4105f3-d08b-edb5-e063-6394a90ad28b2026-11-01WarningsExact identifier
unii: 15FIX9V2JP
HERA SILKYSTAY FOUNDATION 28O1TITANIUM DIOXIDEAmorepacific Corporation5ec77f7a-4621-ac0c-e063-6294a90a3f702026-10-26WarningsExact identifier
unii: 15FIX9V2JP
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 50 (Light)TITANIUM DIOXIDE, ZINC OXIDEZO Skin Health Inc.4f8756bf-5b0d-5269-e063-6294a90ae6dc2026-10-02WarningsExact identifier
unii: 15FIX9V2JP
Wet Ones Hand Sanitizer Mist Lavender BlossomETHYL ALCOHOLEdgewell Personal Care Brands LLCdae52e15-9161-c8d2-e053-2a95a90adb982026-09-29WarningsExact identifier
unii: 3K9958V90M
SOUR LEMON HAND SANITIZER Pink Guava SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO0adfe188-4613-47dc-a9a3-5c9cfca781a82026-09-17WarningsExact identifier
unii: 3K9958V90M
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
hand sanitizer chocolate chip cookie scentETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO69d423f2-ff9f-48e0-a553-c7f4aaf37b292026-09-17WarningsExact identifier
unii: 3K9958V90M
Doxycycline HyclateDOXYCYCLINE HYCLATEREMEDYREPACK INC.051654c7-8ba6-44f2-842c-72f515e9b32d2026-09-15Warnings, Adverse reactionsExact identifier
unii: 19XTS3T51U
doxycycline hyclateDOXYCYCLINE HYCLATEHAWAII REPACK, INC88c429a1-351d-432e-b69b-d7a0afca482a2026-09-09Warnings, Adverse reactionsExact identifier
rxcui: 1649988
unii: 19XTS3T51U
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Advanced Alcohol Gel SanitizerALCOHOLBetco Corporation, Ltda23b997c-b010-5985-e053-2995a90aadf32026-09-09WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hydrating Hand Sanitizer Cotton CandyALCOHOLChurch & Dwight Co., Inc.5b107dd2-a76c-9c80-e063-6394a90aaedb2026-09-09WarningsExact identifier
unii: 3K9958V90M
Pink Touchland Power Mist Hydrating Hand Sanitizer Wild WatermelonALCOHOLChurch & Dwight Co., Inc.5b108f13-6474-fdbd-e063-6294a90a1a2b2026-09-09WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hydrating Hand Sanitizer Mango PassionALCOHOLChurch & Dwight Co., Inc.5b1099ae-f1e8-b79d-e063-6394a90add6f2026-09-09WarningsExact identifier
unii: 3K9958V90M
Touchland Gentle Mist Hand Sanitizer Lily of The ValleyALCOHOLChurch & Dwight Co., Inc.5b10a3a7-1cca-2a34-e063-6294a90a3f6c2026-09-09WarningsExact identifier
unii: 3K9958V90M
Touchland Glow Mist Hand Sanitizer RosewaterALCOHOLChurch & Dwight Co., Inc.5a850866-bc5d-e595-e063-6394a90a335f2026-09-09WarningsExact identifier
unii: 3K9958V90M
Doxycycline HyclateDOXYCYCLINE HYCLATEA-S Medication Solutions9ecadbc8-3087-4692-916a-b7f392d8e8da2026-09-09Warnings, Adverse reactionsExact identifier
application number: ANDA062396
rxcui: 1649405
unii: 19XTS3T51U
hand sanitizer - cherry sundaeALCOHOLGanzhou Olivee Cosmetic Co., Ltd.270d2ce0-6310-4a84-be8a-72db6062bae72026-09-07WarningsExact identifier
unii: 3K9958V90M
hand sanitizer - vanilla frostingALCOHOLGanzhou Olivee Cosmetic Co., Ltd.f6cabda2-6e1c-4238-9a2e-df10e263517d2026-09-07WarningsExact identifier
unii: 3K9958V90M
hydrating mist hand sanitizer with silicone keychain holder - beaver nuggetsALCOHOLGanzhou Olivee Cosmetic Co., Ltd.ba3612b3-9696-417a-ba66-eb9dc5ea27c62026-09-07WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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