FDA.reportPublic FDA data

NDC 11822-0788-05 - Naproxen Sodium

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
11822-0788
Requested NDC
11822-0788-05
Package NDCs from labels
11822-0788-4, 11822-0788-5, 11822-0788-6, 11822-0788-05
Manufacturer
Rite Aid Corporation | Bionpharma Inc. | Patheon Softgels Inc.
Effective date
2023-03-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Naproxen Sodium Capsules - Rite AidRite Aid Corporation | Bionpharma Inc. | Patheon Softgels Inc.2023-03-03HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-0788-4Naproxen Sodium1 in 1 CARTONCAPSULE, LIQUID FILLED16
11822-0788-4Naproxen Sodium40 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED406
11822-0788-5Naproxen Sodium80 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED806
11822-0788-6Naproxen Sodium50 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED506
11822-0788-6Naproxen Sodium1 in 1 CARTONCAPSULE, LIQUID FILLED16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0788NAPROXEN SODIUM CAPSULE, LIQUID FILLED [RITE AID CORPORATION]6Current NDC, Legacy NDC, 5 package rows20230306_a359c47e-e2b4-5560-e053-2a95a90a2844.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 1 of 46 · 920 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDECardinal Healthaee4bbe2-4f11-4c54-be8b-df48b3ba4f3a2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMRite Aid Corporation407c78ca-6fee-4ed6-b61b-711ec049c86e2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
Clear Eyes NighttimeGLYCERINPrestige Brands Holdings, Inc.af75e2f7-81dd-43e0-a390-b52bbfbebf622026-09-08WarningsExact identifier
unii: PDC6A3C0OX
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: FZ989GH94E
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMCVS Pharmacy3167c918-a7d3-46a1-a85b-64f9c22916f22026-09-04WarningsExact identifier
unii: PDC6A3C0OX
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Naproxen SodiumNAPROXEN SODIUMBryant Ranch Prepackf6f4a670-235e-4235-84a8-a74dc8ca55862026-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9TN87S3A3C
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: 6DC9Q167V3
unii: FZ989GH94E
Naproxen SodiumNAPROXEN SODIUMBryant Ranch Prepack2794b60d-d09b-4115-9ff2-07ff15524e782026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9TN87S3A3C
Naproxen SodiumNAPROXEN SODIUMTARGET Corporation36ce5cd9-8c61-4ed9-b840-c29ad98bdfc52026-08-20WarningsExact identifier
rxcui: 1112231
unii: 9TN87S3A3C
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: 6DC9Q167V3
unii: FZ989GH94E
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: 6DC9Q167V3
unii: FZ989GH94E
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: PDC6A3C0OX
NaproxenNAPROXEN SODIUML.N.K. International, Inc.82412133-c11a-4905-a119-965f44de10b72026-08-17WarningsExact identifier
unii: 9TN87S3A3C
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
BM BM164 DROPSARUM TRYPH, CAUSTICUM, BALSAMUM PERU, HELONIAS DIO, ACID PHOS, GLYCERINUM, EQUISETUMBM Private Limited5902770f-eb01-d099-e063-6394a90ad3eb2026-08-14WarningsExact identifier
unii: PDC6A3C0OX
Naproxen SodiumNAPROXEN SODIUMHarris Teeter27938b08-ff37-4587-aa81-5ec3ef21a28a2026-08-12WarningsExact identifier
unii: 9TN87S3A3C
Naproxen SodiumNAPROXEN SODIUMHarris Teeter38543976-ccbe-4af9-b01d-ae102452d4182026-08-12WarningsExact identifier
unii: 9TN87S3A3C

Reported adverse events (FAERS/openFDA)#

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