FDA.reportPublic FDA data

NDC 35561-357-26 - CARBAMAZEPINE ER

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
35561-357
Requested NDC
35561-357-26
Package NDCs from labels
35561-357-12, 35561-357-13, 35561-357-26, 35561-357-99
Manufacturer
Bostal LLC
Effective date
2026-04-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CARBAMAZEPINE ER - Bostal LLCBostal LLC2026-04-29HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
35561-357-122026-01-29C16284748780-149896155-c2f9-586f-e063-e6dba90add90Carbamazepine Extended-Release Tablets, USP 100 mg, 200 mg, 400 mg Rx only Prescribing Information
35561-357-122026-01-29C16284748780-149896155-c2f9-586f-e063-e6dba90add90Carbamazepine Extended-Release Tablets, USP 100 mg, 200 mg, 400 mg Rx only Prescribing Information
35561-357-122026-01-29C16284748780-149896155-c2f9-586f-e063-e6dba90add90Carbamazepine Extended-Release Tablets, USP 100 mg, 200 mg, 400 mg Rx only Prescribing Information

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35561-357-12CARBAMAZEPINE ER100 in 1 BOTTLETABLET, EXTENDED RELEASE1009
35561-357-13CARBAMAZEPINE ER500 in 1 BOTTLETABLET, EXTENDED RELEASE5009
35561-357-26CARBAMAZEPINE ER30 in 1 CARTONTABLET, EXTENDED RELEASE309
35561-357-99CARBAMAZEPINE ER33051 in 1 DRUMTABLET, EXTENDED RELEASE330519

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35561-357CARBAMAZEPINE ER (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [AUSTARPHARMA LLC]4Current NDC, Legacy NDC, 4 package rows20241027_b48741b3-0889-47b8-a26e-b12614f6e7fc.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 20 of 106 · 2,108 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2CR Cool FosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior6cb14dcf-8b70-40c3-882b-063d8922ce4c2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diore4dbfd77-0eec-4d1a-94d6-4daca096d8c72026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior72569958-cd7d-4d52-add4-2b13706e1b1e2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2WO Warm OliveOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior0f5aa600-4168-419b-95d7-569764b5f0b92026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2WP Warm PeachOCTISALATE, TITANIUM DIOXIDEParfums Christian Diore5ab0cd9-ae7f-4558-b5ab-e0b5826772242026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb9fa3bb9-12ec-40d8-b433-a96d9d00cc902026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3C CoolOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorf7b2e348-2c7f-4ff5-8ab0-a3475c9d1f262026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior69924eb8-a8ca-4ea0-b087-c865a6a1313f2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3CR Cool FosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior5cafac21-fb2d-4d63-a7fe-01bf53b941e82026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorbfc27e8d-e59b-46f7-aec9-2a96a00a7c1c2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3WP Warm PeachOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior8fd56c86-ef37-4f31-87d1-6283a19c84242026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4C CoolOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior91b62ba7-2deb-47e6-b9af-25bb459b4d752026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3WO Warm OliveOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior6eec7554-38ed-48d4-916d-ab3660fbf7032026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior939e6d5c-3dd7-4b01-af18-697dc4ba2d992026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4,5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior7149784b-3548-4643-abf6-58fde237bb982026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior061181d8-5387-4541-a7d7-426cba5997a02026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4WO Warm OliveOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorf6ad554a-4795-4149-b066-c53a0989470e2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior58efeaaf-d3c6-44e9-b60f-8f22f5bb1d332026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4WP Warm PeachOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorf6b4a90b-5905-4f62-9e35-f2b1dda8dddd2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
BRUSH and GO SPF 50 ALL SKIN TYPES BROAD SPECTRUMTITANIUM DIOXIDE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND OXYBENZONENoon Aesthetics M.R. Ltd0d9f132c-7630-4261-a0f8-fc7a4377731f2026-01-16WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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