FDA.reportPublic FDA data

NDC 68084-446-11 - Nitrofurantoin (monohydrate/macrocrystals)

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
68084-446
Requested NDC
68084-446-11
Package NDCs from labels
68084-446-11, 68084-446-01
Manufacturer
American Health Packaging
Effective date
2022-10-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Nitrofurantoin (monohydrate/macrocrystals) - American Health PackagingAmerican Health Packaging2022-10-19HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-446-01EA - Each68084-4463531bb3c-0cf0-4c41-ac4f-07e04cce734112012-07-24
68084-446-11EA - Each68084-446c2e616ac-22cd-4470-8909-ecaf9f724e9b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NITROFURANTOINACTIVE INGREDIENT927AH8112LNITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [AMERICAN HEALTH PACKAGING]2
NITROFURANTOIN MONOHYDRATEACTIVE INGREDIENTE1QI2CQQ1INITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [AMERICAN HEALTH PACKAGING]2
NITROFURANTOINACTIVE MOIETY927AH8112LNITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [AMERICAN HEALTH PACKAGING]2
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENTZ135WT9208NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [AMERICAN HEALTH PACKAGING]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [AMERICAN HEALTH PACKAGING]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [AMERICAN HEALTH PACKAGING]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [AMERICAN HEALTH PACKAGING]2
GELATININACTIVE INGREDIENT2G86QN327LNITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [AMERICAN HEALTH PACKAGING]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [AMERICAN HEALTH PACKAGING]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [AMERICAN HEALTH PACKAGING]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ENITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [AMERICAN HEALTH PACKAGING]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [AMERICAN HEALTH PACKAGING]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [AMERICAN HEALTH PACKAGING]2
TALCINACTIVE INGREDIENT7SEV7J4R1UNITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [AMERICAN HEALTH PACKAGING]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [AMERICAN HEALTH PACKAGING]2

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 24 of 142 · 2,832 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorf560de93-4099-4ad9-8eb6-fe2a52ac82a12026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior824c5f13-970e-4e9e-8f2a-2a01973d2e592026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb7621ef5-47fc-4ccc-aedd-eac328ace7b92026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3C CoolOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior64a29ff8-e24d-4818-9b54-734a0eb2a13f2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2WP Warm PeachOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior17a0201b-b797-4e65-838f-1ce8d408a0202026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2WO Warm OliveOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior72e2c71a-da1d-497f-a8b7-491cff951c632026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3CR Cool FosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior19d1432a-96b0-4cef-b13e-895dd41b41d62026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior5a06c820-ccd8-47ce-8bbf-7e90da92b1de2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior205e195a-fd30-44f7-9294-e701f0f766d62026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3WP Warm PeachOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior5495ff75-0c83-4491-8af7-4aed7a779d7f2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3WO Warm OliveOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior10bc345d-a5b1-4b70-bfa6-a2d7816904bf2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior30268b6e-d42a-4314-b82f-24f9e81cca2a2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4,5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior545c962f-2a59-4d94-8fef-ebdba4127f422026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4C CoolOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior17c9226b-459c-42fe-ac50-7e26db6b49af2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior8cb27c4e-b2f4-4e60-a5ff-7cdda79a3af62026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorbf323e10-5479-44b3-b4b9-b8ca6b0f76882026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4WO Warm OliveOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior2d6a5133-b847-4ecf-8c33-1cb05aca6b912026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4WP Warm PeachOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior275be888-2c52-43ed-846a-55525002edcd2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 6,5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorc73576a6-dbab-4205-add5-876a060b50222026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 wless Skin True Foundation SPF 20 7,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior4ae761ac-df06-4913-a8bf-8ca1be32b5b72026-01-16WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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