FDA.reportPublic FDA data

NDC 17856-0620-04 - Baclofen

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
17856-0620
Requested NDC
17856-0620-04
Package NDCs from labels
17856-0620-1, 17856-0620-2, 17856-0620-3, 17856-0620-4, 17856-0620-5, 17856-0620-9, 17856-0620-04
Manufacturer
Atlantic Biologicals Corp.
Effective date
2026-09-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Baclofen - Atlantic Biologicals Corp.Atlantic Biologicals Corp.2026-09-04HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0620-1Baclofen2.5 mL in 1 CUP, UNIT-DOSESOLUTION2.52
17856-0620-1Baclofen72 in 1 CASESOLUTION722
17856-0620-2Baclofen5 mL in 1 CUP, UNIT-DOSESOLUTION52
17856-0620-2Baclofen72 in 1 CASESOLUTION722

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 32 · 633 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BACLOFENBACLOFENREMEDYREPACK INC.ab3760cd-a84b-49ba-88e3-b9ea73c55f822026-09-09Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
Leader Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDECardinal Healthaee4bbe2-4f11-4c54-be8b-df48b3ba4f3a2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
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
BaclofenBACLOFENAtlantic Biologicals Corp.50b3e7be-832b-313d-e063-6394a90a5ab42026-09-04Warnings, Adverse reactionsExact identifier
application number: NDA208193
ndc (package): 17856-0620-5
ndc (package): 17856-0620-2
ndc (package): 17856-0620-4
ndc (package): 17856-0620-1
ndc (package): 17856-0620-3
ndc (package): 17856-0620-9
ndc (product): 17856-0620
ndc11 (package): 17856062004
rxcui: 2667941
spl id: 5aae5fc2-e3b8-4974-e063-6294a90a113d
spl set id: 50b3e7be-832b-313d-e063-6394a90a5ab4
unii: H789N3FKE8
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMCVS Pharmacy3167c918-a7d3-46a1-a85b-64f9c22916f22026-09-04WarningsExact identifier
unii: PDC6A3C0OX
BACLOFENBACLOFENREMEDYREPACK INC.4e2cd27d-91c7-4f15-96cc-3971769dbeaa2026-09-03Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
BACLOFENBACLOFENREMEDYREPACK INC.c2e1d183-7061-459b-a631-206b06d127532026-09-01Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BaclofenBACLOFENPar Health USA, LLCc17527be-661d-42f5-b6f6-56a681ba78702026-08-24Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
BaclofenBACLOFENBryant Ranch Prepackaeb56b0e-7126-4417-b726-e8a54f73de3f2026-08-24Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: PDC6A3C0OX
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
BACLOFENBACLOFENREMEDYREPACK INC.ac9b720f-b755-49f1-9850-efb26feadaeb2026-08-14Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
BACLOFENBACLOFENREMEDYREPACK INC.355266e4-68f7-47d7-9f4e-1a0fc912786d2026-08-10Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BaclofenBACLOFENREMEDYREPACK INC.76896b07-2835-4467-b386-87ec66ddd88e2026-08-04Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
CVS GlycerinGLYCERIN SUPPOISITORYCVS Pharmacy, Incca6d13db-60e8-4fcc-b7b3-3eb280b8c4352026-08-04WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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