Advil

Product NDC
0573-0133
11-digit product format
005730133
Labeler code
0573
Product ID
0573-0133_40429ef4-846a-eb4c-e063-6394a90ab7a9
Type
HUMAN OTC DRUG
Nonproprietary name
ibuprofen sodium
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
NDA201803
Marketing category
NDA
Marketing start
2013-07-08
Substance
IBUPROFEN SODIUM
Active strength
256 mg/1
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N201803-001ADVILIBUPROFEN SODIUMEQ 200MG BASETABLET / ORALRLD, RS2012-06-12

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N201803-001ADVILEQ 200MG BASETABLET / ORALRLD, RS2012-06-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N201803-001ADVILEQ 200MG BASETABLET / ORALRLD, RS2012-06-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N201803-001ADVILEQ 200MG BASETABLET / ORALRLD, RS2012-06-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08N201803-001ADVILEQ 200MG BASETABLET / ORALRLD, RS2012-06-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N201803-001ADVILEQ 200MG BASETABLET / ORALRLD, RS2012-06-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N201803-001ADVILEQ 200MG BASETABLET / ORALRLD, RS2012-06-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N201803-001ADVILEQ 200MG BASETABLET / ORALRLD, RS2012-06-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N201803-001ADVILEQ 200MG BASETABLET / ORALRLD, RS2012-06-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N201803-001ADVILEQ 200MG BASETABLET / ORALRLD, RS2012-06-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N201803-001ADVILEQ 200MG BASETABLET / ORALRLD, RS2012-06-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N201803-001ADVILEQ 200MG BASETABLET / ORALRLD, RS2012-06-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N201803-001ADVILEQ 200MG BASETABLET / ORALRLD, RS2012-06-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N201803-001ADVILEQ 200MG BASETABLET / ORALRLD, RS2012-06-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N201803-001ADVILEQ 200MG BASETABLET / ORALRLD, RS2012-06-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05N201803-001ADVILEQ 200MG BASETABLET / ORALRLD, RS2012-06-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N201803-001ADVILEQ 200MG BASETABLET / ORALRLD, RS2012-06-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N201803-001ADVILEQ 200MG BASETABLET / ORALRLD, RS2012-06-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N201803-001ADVILEQ 200MG BASETABLET / ORALRLD, RS2012-06-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N201803-001ADVILEQ 200MG BASETABLET / ORALRLD, RS2012-06-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N201803-001ADVILEQ 200MG BASETABLET / ORALRLD, RS2012-06-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N201803-001ADVILEQ 200MG BASETABLET / ORALRLD, RS2012-06-12782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N201803-001ADVILEQ 200MG BASETABLET / ORALRLD, RS2012-06-1287673890dc5c…
2021-03-12 10:30 UTC2021-03N201803-001ADVILEQ 200MG BASETABLET / ORALRLD, RS2012-06-125aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N201803-001ADVILEQ 200MG BASETABLET / ORALRLD, RS2012-06-128869cabd3fbd…
2020-11-12 02:37 UTC2020-11N201803-001ADVILEQ 200MG BASETABLET / ORALRLD, RS2012-06-12c0c555d07b60…
2019-12-14 00:12 UTC2019-12N201803-001ADVILEQ 200MG BASETABLET / ORALRLD, RS2012-06-123f01610625f2…
2019-09-15 20:21 UTC2019-09N201803-001ADVILEQ 200MG BASETABLET / ORALRLD, RS2012-06-12b00525d2431f…
2019-07-19 19:46 UTC2019-07N201803-001ADVILEQ 200MG BASETABLET / ORALRLD, RS2012-06-12ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N201803-001ADVILEQ 200MG BASETABLET / ORALRLD, RS2012-06-126a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N201803-001ADVILEQ 200MG BASETABLET / ORALRLD, RS2012-06-121c564ffb4f44…
2023-12-20 04:57 UTC2023-12N201803-001ADVILEQ 200MG BASETABLET / ORALRLD, RS2012-06-12ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N201803-001ADVILEQ 200MG BASETABLET / ORALRLD, RS2012-06-12a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N201803-001ADVILEQ 200MG BASETABLET / ORALRLD, RS2012-06-129b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N201803-001ADVILEQ 200MG BASETABLET / ORALRLD, RS2012-06-12a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N201803-001ADVILEQ 200MG BASETABLET / ORALRLD, RS2012-06-123f0d92c62455…
2023-05-13 08:27 UTC2023-05N201803-001ADVILEQ 200MG BASETABLET / ORALRLD, RS2012-06-12053a50430f4f…
2023-01-26 05:58 UTC2023-01N201803-001ADVILEQ 200MG BASETABLET / ORALRLD, RS2012-06-123bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N201803-001ADVILEQ 200MG BASETABLET / ORALRLD, RS2012-06-123a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N201803-001ADVILEQ 200MG BASETABLET / ORALRLD, RS2012-06-12f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N201803-001ADVILEQ 200MG BASETABLET / ORALRLD, RS2012-06-12e64feba35796…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN SODIUM256 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
RM1CE97Z4NInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
153008Internal RxNorm lookup
310965Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5be198b8-396e-4b44-8819-e2e3b5d2ad0eAvailable on FDA.report

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
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-0133-01Advil2 in 1 PACKETTABLET, COATED220
0573-0133-01Advil3000 in 1 CASETABLET, COATED300020
0573-0133-02Advil2 in 1 PACKETTABLET, COATED220
0573-0133-02Advil50 in 1 TRAYTABLET, COATED5020
0573-0133-04Advil2 in 1 BLISTER PACKTABLET, COATED220
0573-0133-04Advil2 in 1 PACKETTABLET, COATED220
0573-0133-05Advil2 in 1 CARTONTABLET, COATED220
0573-0133-05Advil2 in 1 PACKETTABLET, COATED220
0573-0133-20Advil20 in 1 BOTTLETABLET, COATED2020
0573-0133-20Advil1 in 1 CARTONTABLET, COATED120
0573-0133-40Advil1 in 1 CARTONTABLET, COATED120
0573-0133-40Advil40 in 1 BOTTLETABLET, COATED4020
0573-0133-41Advil40 in 1 BOTTLETABLET, COATED4020
0573-0133-41Advil1 in 1 CARTONTABLET, COATED120
0573-0133-80Advil1 in 1 CARTONTABLET, COATED120
0573-0133-80Advil80 in 1 BOTTLETABLET, COATED8020
0573-0133-81Advil100 in 1 BOTTLETABLET, COATED10020
0573-0133-81Advil1 in 1 CARTONTABLET, COATED120
0573-0133-88Advil120 in 1 BOTTLETABLET, COATED12020
0573-0133-88Advil2 in 1 PACKAGETABLET, COATED220
0573-0133-89Advil1 in 1 CARTONTABLET, COATED120
0573-0133-89Advil160 in 1 BOTTLETABLET, COATED16020
0573-0133-91Advil1 in 1 CARTONTABLET, COATED120
0573-0133-91Advil180 in 1 BOTTLETABLET, COATED18020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-0133-05EA - Each0573-013317b8a8fd-9081-4699-81a0-61dc7ed5163d12019-06-19
0573-0133-20EA - Each0573-01332dfaeb1d-708e-4b9f-bbec-e46f863f724712019-06-19
0573-0133-40EA - Each0573-013360bda876-b406-4188-bd44-f58fe62dc55912019-06-19
0573-0133-80EA - Each0573-0133cc5678ef-2794-42cc-8b4d-57a120005bb812015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFEN SODIUMACTIVE INGREDIENTRM1CE97Z4NADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]9
IBUPROFENACTIVE MOIETYWK2XYI10QMADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]9
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9ADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]9
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]9
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]9
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]9
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]9
MANNITOLINACTIVE INGREDIENT3OWL53L36AADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]9
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]9
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]9
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]9
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]9
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]9
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4ADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-0133ADVIL (IBUPROFEN SODIUM) TABLET, COATED [HALEON US HOLDINGS LLC]19Current NDC, Legacy NDC, 24 package rows20240625_5be198b8-396e-4b44-8819-e2e3b5d2ad0e.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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Advil Menstrual PainIBUPROFEN SODIUMHaleon US Holdings LLCae1625f4-ef32-4d4f-bf54-c44085843e412026-08-20WarningsExact identifier
application applno (NDA): 201803
application number: NDA201803
AdvilIBUPROFEN SODIUMHaleon US Holdings LLC5be198b8-396e-4b44-8819-e2e3b5d2ad0e2025-10-03WarningsExact identifier
application applno (NDA): 201803
application number: NDA201803
ndc (product): 0573-0133

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
153008Advil 200 MG Oral TabletPSN5be198b8-396e-4b44-8819-e2e3b5d2ad0e20
310965ibuprofen 200 MG Oral TabletPSN5be198b8-396e-4b44-8819-e2e3b5d2ad0e20
153008ibuprofen 200 MG Oral Tablet [Advil]SBD5be198b8-396e-4b44-8819-e2e3b5d2ad0e20
310965ibuprofen 200 MG Oral TabletSCD5be198b8-396e-4b44-8819-e2e3b5d2ad0e20
153008Advil 200 MG Oral TabletSY5be198b8-396e-4b44-8819-e2e3b5d2ad0e20
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY5be198b8-396e-4b44-8819-e2e3b5d2ad0e20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0573-0133-01005730133013000 PACKET in 1 CASE (0573-0133-01) / 2 TABLET, COATED in 1 PACKET3000 packet2014-08-110000-00-00NoNoCurrent
0573-0133-020057301330250 PACKET in 1 TRAY (0573-0133-02) / 2 TABLET, COATED in 1 PACKET50 packet2013-07-080000-00-00NoNoCurrent
0573-0133-04005730133042 PACKET in 1 BLISTER PACK (0573-0133-04) / 2 TABLET, COATED in 1 PACKET2 packet2013-07-080000-00-00NoNoCurrent
0573-0133-05005730133052 PACKET in 1 CARTON (0573-0133-05) / 2 TABLET, COATED in 1 PACKET2 packet2013-07-080000-00-00NoNoCurrent
0573-0133-20005730133201 BOTTLE in 1 CARTON (0573-0133-20) / 20 TABLET, COATED in 1 BOTTLE1 bottle2013-07-080000-00-00NoNoCurrent
0573-0133-40005730133401 BOTTLE in 1 CARTON (0573-0133-40) / 40 TABLET, COATED in 1 BOTTLE1 bottle2013-07-080000-00-00NoNoCurrent
0573-0133-41005730133411 BOTTLE in 1 CARTON (0573-0133-41) / 40 TABLET, COATED in 1 BOTTLE1 bottle2015-08-120000-00-00NoNoCurrent
0573-0133-80005730133801 BOTTLE in 1 CARTON (0573-0133-80) / 80 TABLET, COATED in 1 BOTTLE1 bottle2013-07-080000-00-00NoNoCurrent
0573-0133-81005730133811 BOTTLE in 1 CARTON (0573-0133-81) / 100 TABLET, COATED in 1 BOTTLE1 bottle2013-07-080000-00-00NoNoCurrent
0573-0133-88005730133882 BOTTLE in 1 PACKAGE (0573-0133-88) / 120 TABLET, COATED in 1 BOTTLE2 bottle2013-07-080000-00-00NoNoCurrent
0573-0133-89005730133891 BOTTLE in 1 CARTON (0573-0133-89) / 160 TABLET, COATED in 1 BOTTLE1 bottle2013-07-080000-00-00NoNoCurrent
0573-0133-91005730133911 BOTTLE in 1 CARTON (0573-0133-91) / 180 TABLET, COATED in 1 BOTTLE1 bottle2014-12-010000-00-00NoNoCurrent