FDA.reportPublic FDA data

NDC 0591-5631 - Doxepin 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
0591-5631
Package NDCs from labels
0591-5631-01, 0591-5631-10
Manufacturer
Watson Laboratories, Inc.
Effective date
2007-10-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Doxepin Hydrochloride Capsules USP Revised: August 2007 Rx onlyWatson Laboratories, Inc.2007-10-25HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-5631-01Doxepin Hydrochloride100 in 1 BOTTLECAPSULE10013
0591-5631-10Doxepin Hydrochloride1000 in 1 BOTTLECAPSULE100013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-5631DOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]132 package rows20071109_AA69C63C-CED6-4676-A16B-554F1AF7D210.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Doxepin hydrochlorideACTIVE INGREDIENT3U9A0FE9N5DOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]13
DoxepinACTIVE MOIETY5ASJ6HUZ7DDOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]13
colloidal silicon dioxideINACTIVE INGREDIENTDOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]13
D & C Yellow No. 10INACTIVE INGREDIENTDOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]13
FD & C Green No. 3INACTIVE INGREDIENTDOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]13
FD & C Yellow No. 6INACTIVE INGREDIENTDOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]13
gelatinINACTIVE INGREDIENT2G86QN327LDOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]13
magnesium stearateINACTIVE INGREDIENT70097M6I30DOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]13
pregelatinzed starchINACTIVE INGREDIENTDOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]13
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4DOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]13
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JDOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]13
starch (corn)INACTIVE INGREDIENTDOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]13
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]13

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 4 · 75 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEREMEDYREPACK INC.21dc77be-23af-4a1f-b189-dfee8ae2f8942026-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000076
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEREMEDYREPACK INC.670edc2b-7914-479e-b4dd-d5c86706a6312026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000076
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEREMEDYREPACK INC.d29a8c70-cf1c-4bf8-bb87-1c80babce64e2026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEREMEDYREPACK INC.90d9041f-985b-470b-8cbb-f05dbfc770c92026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000048
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEREMEDYREPACK INC.5ee0f8e6-df05-4166-a614-77e124db95ae2026-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000097
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEREMEDYREPACK INC.99ff6e3e-8c12-4393-96ae-206d86d269472026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000058
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDENovadoz Pharmaceuticals LLC2b1f0144-65d8-451f-8054-6be1675f102c2026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000048
rxcui: 1000097
rxcui: 1000070
rxcui: 1000058
rxcui: 1000076
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEA-S Medication Solutions78cf65ff-43f9-4f5e-95dd-864acc89c02a2026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000048
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEProficient Rx LPd7a6768a-927b-4f51-858d-1ddfa9d5c5d32026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000048
Doxepin hydrochlorideDOXEPIN HYDROCHLORIDEREMEDYREPACK INC.46be666a-fb9f-42a5-a55c-ea15fd5538c92026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000076
Doxepin hydrochlorideDOXEPIN HYDROCHLORIDEREMEDYREPACK INC.4ecd3b43-b5f1-4cf4-af36-eb214c1a3c602026-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000048
Doxepin hydrochlorideDOXEPIN HYDROCHLORIDECoupler LLC54616c93-2325-4719-e063-6394a90a39102026-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000076
Doxepin hydrochlorideDOXEPIN HYDROCHLORIDECoupler LLC538643c0-b8d1-d71f-e063-6294a90a77342026-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEBryant Ranch Prepackc577af7c-2405-4454-a169-5b6a4fa0c7bf2026-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDESafecor Health, LLCa2297f75-c498-419b-aa29-057271313a7f2026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000048
rxcui: 1000070
rxcui: 1000058
rxcui: 1000076
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.1ede17e6-19e9-455c-ad16-8029a590735c2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.d2a91b99-513d-4894-ad6d-02d2028a22902026-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000048
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDELeading Pharma, LLCe6a4cb10-1928-4abe-8797-404c9ddc37dd2025-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000048
rxcui: 1000097
rxcui: 1000070
rxcui: 1000058
rxcui: 1000076
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.1496dfc1-de50-471c-be87-1f1e2b70ab5a2025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000070
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEA-S Medication Solutionse0460c02-3dae-4b19-845c-2ffcfb587f6d2025-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000076

Reported adverse events (FAERS/openFDA)#

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