Ibuprofen

Product NDC
17856-5309
11-digit product format
178565309
Labeler code
17856
Product ID
17856-5309_34f37e2c-ba78-120a-e063-6294a90aa750
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA074937
Marketing category
ANDA
Marketing start
1999-02-07
Substance
IBUPROFEN
Active strength
100 mg/5mL
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ibuprofen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN100 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197803

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-5309-12025-03-28C16284748780-1f386c64a-321d-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-22025-03-28C16284748780-1f386c64a-321d-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-32025-03-28C16284748780-1f386c64a-321d-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-42025-03-28C16284748780-1f386c64a-321d-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-52025-03-28C16284748780-1f386c64a-321d-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-62025-03-28C16284748780-1f386c64a-321d-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-72025-03-28C16284748780-1f386c64a-321d-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-92025-03-28C16284748780-1f386c64a-321d-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-12025-01-30C16284748780-1f386c64a-321d-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-22025-01-30C16284748780-1f386c64a-321d-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-32025-01-30C16284748780-1f386c64a-321d-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-42025-01-30C16284748780-1f386c64a-321d-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-52025-01-30C16284748780-1f386c64a-321d-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-62025-01-30C16284748780-1f386c64a-321d-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-72025-01-30C16284748780-1f386c64a-321d-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-92025-01-30C16284748780-1f386c64a-321d-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-12023-12-12C16284748780-1f386c64a-321d-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-22023-12-12C16284748780-1f386c64a-321d-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-32023-12-12C16284748780-1f386c64a-321d-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-42023-12-12C16284748780-1f386c64a-321d-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-52023-12-12C16284748780-1f386c64a-321d-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-62023-12-12C16284748780-1f386c64a-321d-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-72023-12-12C16284748780-1f386c64a-321d-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-92023-12-12C16284748780-1f386c64a-321d-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-12023-01-30C16284748780-1f386c64a-321d-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-22023-01-30C16284748780-1f386c64a-321d-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-32023-01-30C16284748780-1f386c64a-321d-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-42023-01-30C16284748780-1f386c64a-321d-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-52023-01-30C16284748780-1f386c64a-321d-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-62023-01-30C16284748780-1f386c64a-321d-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-72023-01-30C16284748780-1f386c64a-321d-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-92023-01-30C16284748780-1f386c64a-321d-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-5309-1Ibuprofen5 mL in 1 SYRINGESUSPENSION512
17856-5309-2Ibuprofen10 mL in 1 SYRINGESUSPENSION1012
17856-5309-3Ibuprofen1 mL in 1 SYRINGESUSPENSION112
17856-5309-4Ibuprofen20 mL in 1 CUPSUSPENSION2012
17856-5309-5Ibuprofen5 mL in 1 CUPSUSPENSION512
17856-5309-6Ibuprofen15 mL in 1 CUPSUSPENSION1512
17856-5309-7Ibuprofen7.5 mL in 1 CUP, UNIT-DOSESUSPENSION7.512
17856-5309-8Ibuprofen10 mL in 1 CUP, UNIT-DOSESUSPENSION1012
17856-5309-8Ibuprofen72 in 1 CASESUSPENSION7212
17856-5309-9Ibuprofen1 mL in 1 SYRINGESUSPENSION112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-5309-5ML - Milliliter17856-53092367354b-add7-439f-ad0e-568dbf9cef4412013-06-04
17856-5309-8ML - Milliliter17856-530957fe7af4-f076-4408-a7bf-96e936366e4212026-02-05

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-5309IBUPROFEN SUSPENSION [ATLANTIC BIOLOGICALS CORP.]12Current NDC, Legacy NDC, 10 package rows20250514_230914e6-fe0c-45be-8b2e-e066c71d004c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSN230914e6-fe0c-45be-8b2e-e066c71d004c12
197803ibuprofen 20 MG/ML Oral SuspensionSCD230914e6-fe0c-45be-8b2e-e066c71d004c12
197803ibuprofen 100 MG per 5 ML Oral SuspensionSY230914e6-fe0c-45be-8b2e-e066c71d004c12
197803ibuprofen 200 MG per 10 ML Oral SuspensionSY230914e6-fe0c-45be-8b2e-e066c71d004c12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-5309-1178565309015 mL in 1 SYRINGE (17856-5309-1) 5 ml2021-01-280000-00-00NoNoCurrent
17856-5309-21785653090210 mL in 1 SYRINGE (17856-5309-2) 10 ml2019-09-20NoNoCurrent
17856-5309-3178565309031 mL in 1 SYRINGE1 mlHistorical
17856-5309-41785653090420 mL in 1 CUP (17856-5309-4) 20 ml2021-01-280000-00-00NoNoCurrent
17856-5309-5178565309055 mL in 1 CUP (17856-5309-5) 5 ml2021-01-280000-00-00NoNoCurrent
17856-5309-61785653090615 mL in 1 CUP (17856-5309-6) 15 ml2021-01-280000-00-00NoNoCurrent
17856-5309-7178565309077.5 mL in 1 CUP, UNIT-DOSE (17856-5309-7) 7.5 ml2021-01-280000-00-00NoNoCurrent
17856-5309-81785653090872 CUP, UNIT-DOSE in 1 CASE (17856-5309-8) / 10 mL in 1 CUP, UNIT-DOSE2025-04-02NoNoCurrent
17856-5309-9178565309091 mL in 1 SYRINGE (17856-5309-9) 1 ml2021-01-280000-00-00NoNoCurrent