FDA.reportPublic FDA data

NDC 80425-0501-07 - Tramadol Hydrochloride

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
80425-0501
Requested NDC
80425-0501-07
Package NDCs from labels
80425-0501-1, 80425-0501-2, 80425-0501-3, 80425-0501-4, 80425-0501-5, 80425-0501-7, 80425-0501-8, 80425-0501-6, 80425-0501-07
Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2025-02-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Tramadol Hydrochloride - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2025-02-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0501-1Tramadol Hydrochloride15 in 1 BOTTLETABLET, COATED151
80425-0501-2Tramadol Hydrochloride30 in 1 BOTTLETABLET, COATED301
80425-0501-3Tramadol Hydrochloride60 in 1 BOTTLETABLET, COATED601
80425-0501-4Tramadol Hydrochloride90 in 1 BOTTLETABLET, COATED901
80425-0501-5Tramadol Hydrochloride120 in 1 BOTTLETABLET, COATED1201
80425-0501-6Tramadol Hydrochloride40 in 1 BOTTLETABLET, COATED401
80425-0501-7Tramadol Hydrochloride180 in 1 BOTTLETABLET, COATED1801
80425-0501-8Tramadol Hydrochloride240 in 1 BOTTLETABLET, COATED2401

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0501TRAMADOL HYDROCHLORIDE TABLET, COATED [ADVANCED RX OF TENNESSEE, LLC]1Current NDC, 8 package rows20250221_2e738ced-9cde-e776-e063-6294a90a7e33.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0501-1EA - Each80425-05015b367eca-98d7-4034-a218-38197df636e712025-03-04
80425-0501-2EA - Each80425-0501b9cf99f9-897c-4f4f-94f6-3ccaf4f83a9212025-03-04
80425-0501-3EA - Each80425-0501b7c9bbe8-370c-428d-b7d8-916758373a8912025-03-04
80425-0501-4EA - Each80425-0501756c208b-56a5-4df6-9f17-65c41677bde512025-03-04
80425-0501-5EA - Each80425-05011f8064f3-66bb-4859-850f-f42fbc72a96c12025-03-04
80425-0501-6EA - Each80425-0501f406d2e2-a3ba-40aa-a5a7-fa458eceb81e12025-03-04
80425-0501-7EA - Each80425-05016f965c02-75e5-44aa-b55a-feb03d48262612025-03-04
80425-0501-8EA - Each80425-0501bf6a096b-a9fc-4ba5-92c8-38303e66a4ab12025-03-04

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 8 of 107 · 2,136 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PREMIUM BEAUTY BALM BROAD SPECTRUM SPF 30OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, AND ZINC OXIDEHave & Be Co., Ltd.4a7e868d-6310-6ee4-e063-6394a90aebce2026-05-06WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 1W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior53a79ee7-312b-49a2-8a9b-c50794fcd1712026-05-05WarningsExact identifier
unii: 15FIX9V2JP
Neutrogena MINERAL UV TINT FACE DEEP SPF 30TITANIUM DIOXIDE, ZINC OXIDEPort Jervis Laboratories, Inc51169bed-2091-ad2b-e063-6294a90a84b62026-05-05WarningsExact identifier
unii: 15FIX9V2JP
LUMINOUS EYE CORRECTOR SPF 41 - FAIRTITANIUM DIOXIDE, ZINC OXIDEDrmtlgy, LLC8cfb1f8c-1bd7-4983-ab82-1c9bd8925afa2026-05-04WarningsExact identifier
unii: 15FIX9V2JP
LUMINOUS EYE CORRECTOR SPF 41 - DEEPTITANIUM DIOXIDE, ZINC OXIDEDrmtlgy, LLC930bd1de-5a0e-4607-8d3c-b1ca918f890b2026-05-04WarningsExact identifier
unii: 15FIX9V2JP
LUMINOUS EYE CORRECTOR SPF 41 - MEDIUMTITANIUM DIOXIDE, ZINC OXIDEDrmtlgy, LLC0206c676-c24d-470e-adb2-7cb3173f37272026-05-04WarningsExact identifier
unii: 15FIX9V2JP
LUMINOUS EYE CORRECTOR SPF 41 - TANTITANIUM DIOXIDE, ZINC OXIDEDrmtlgy, LLC5c5aad09-9f93-4634-8db1-c67570b38b2b2026-05-04WarningsExact identifier
unii: 15FIX9V2JP
Blue Lizard Sport SPF 50 SunscreenOCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories4955fa1c-789d-4f42-af75-70223310644a2026-05-01WarningsExact identifier
unii: 15FIX9V2JP
Blue Lizard Kids SPF 50 SunscreenOCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDECrown Laboratoriesba4ae906-48c0-8384-e053-2995a90afb912026-05-01WarningsExact identifier
unii: 15FIX9V2JP
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEST. MARY'S MEDICAL PARK PHARMACYf2f421ab-35ae-7637-e053-2995a90a40e02026-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835603
unii: 9N7R477WCK
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 2CR Cool RosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior6831832a-e52e-43ea-899f-f5d44bea5a942026-04-30WarningsExact identifier
unii: 15FIX9V2JP
Tru Skin Rituals SPF 25TITANIUM DIOXIDE, ZINC OXIDESpa de Soleilf725cd5c-999e-2393-e053-6394a90a09dc2026-04-30WarningsExact identifier
unii: 15FIX9V2JP
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.509cad98-0321-2a0a-e063-6294a90a6ea92026-04-29WarningsExact identifier
unii: 15FIX9V2JP
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.509d7206-0cc1-c997-e063-6294a90a89e02026-04-29WarningsExact identifier
unii: 15FIX9V2JP
JMSOLUTION SKIN BOOST NIACINAMIDE SUNSCREENHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEGPNY CORP211dea04-faad-8ffc-e063-6294a90a8d682026-04-29WarningsExact identifier
unii: 15FIX9V2JP
Anything SPFOCTINOXATE, OCTISALATE, ZINC OXIDE, AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDEAnything SPF LLC508b8dcb-6600-6dad-e063-6294a90a565a2026-04-28WarningsExact identifier
unii: 15FIX9V2JP
Johnsons Baby Mineral Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC4fe04c4b-2751-0561-e063-6394a90af7682026-04-22WarningsExact identifier
unii: 15FIX9V2JP
Lazy Face SPF 30 FacescreenTITANIUM DIOXIDE, ZINC OXIDESunny Day Creations500ee303-7302-68d5-e063-6394a90ac6d42026-04-22WarningsExact identifier
unii: 15FIX9V2JP
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ

Reported adverse events (FAERS/openFDA)#

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