Home NDC 0573-0134 Advil
Product NDC 0573-0134
11-digit product format 005730134
Labeler code 0573
Product ID 0573-0134_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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N201803-001 ADVIL IBUPROFEN SODIUM EQ 200MG BASE TABLET / ORAL RLD, RS 2012-06-12
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N201803-001 ADVIL EQ 200MG BASE TABLET / ORAL RLD, RS 2012-06-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N201803-001 ADVIL EQ 200MG BASE TABLET / ORAL RLD, RS 2012-06-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201803-001 ADVIL EQ 200MG BASE TABLET / ORAL RLD, RS 2012-06-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N201803-001 ADVIL EQ 200MG BASE TABLET / ORAL RLD, RS 2012-06-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201803-001 ADVIL EQ 200MG BASE TABLET / ORAL RLD, RS 2012-06-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201803-001 ADVIL EQ 200MG BASE TABLET / ORAL RLD, RS 2012-06-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N201803-001 ADVIL EQ 200MG BASE TABLET / ORAL RLD, RS 2012-06-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N201803-001 ADVIL EQ 200MG BASE TABLET / ORAL RLD, RS 2012-06-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N201803-001 ADVIL EQ 200MG BASE TABLET / ORAL RLD, RS 2012-06-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N201803-001 ADVIL EQ 200MG BASE TABLET / ORAL RLD, RS 2012-06-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N201803-001 ADVIL EQ 200MG BASE TABLET / ORAL RLD, RS 2012-06-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N201803-001 ADVIL EQ 200MG BASE TABLET / ORAL RLD, RS 2012-06-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N201803-001 ADVIL EQ 200MG BASE TABLET / ORAL RLD, RS 2012-06-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N201803-001 ADVIL EQ 200MG BASE TABLET / ORAL RLD, RS 2012-06-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N201803-001 ADVIL EQ 200MG BASE TABLET / ORAL RLD, RS 2012-06-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N201803-001 ADVIL EQ 200MG BASE TABLET / ORAL RLD, RS 2012-06-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N201803-001 ADVIL EQ 200MG BASE TABLET / ORAL RLD, RS 2012-06-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N201803-001 ADVIL EQ 200MG BASE TABLET / ORAL RLD, RS 2012-06-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N201803-001 ADVIL EQ 200MG BASE TABLET / ORAL RLD, RS 2012-06-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N201803-001 ADVIL EQ 200MG BASE TABLET / ORAL RLD, RS 2012-06-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N201803-001 ADVIL EQ 200MG BASE TABLET / ORAL RLD, RS 2012-06-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N201803-001 ADVIL EQ 200MG BASE TABLET / ORAL RLD, RS 2012-06-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N201803-001 ADVIL EQ 200MG BASE TABLET / ORAL RLD, RS 2012-06-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N201803-001 ADVIL EQ 200MG BASE TABLET / ORAL RLD, RS 2012-06-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N201803-001 ADVIL EQ 200MG BASE TABLET / ORAL RLD, RS 2012-06-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N201803-001 ADVIL EQ 200MG BASE TABLET / ORAL RLD, RS 2012-06-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N201803-001 ADVIL EQ 200MG BASE TABLET / ORAL RLD, RS 2012-06-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N201803-001 ADVIL EQ 200MG BASE TABLET / ORAL RLD, RS 2012-06-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N201803-001 ADVIL EQ 200MG BASE TABLET / ORAL RLD, RS 2012-06-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N201803-001 ADVIL EQ 200MG BASE TABLET / ORAL RLD, RS 2012-06-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N201803-001 ADVIL EQ 200MG BASE TABLET / ORAL RLD, RS 2012-06-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N201803-001 ADVIL EQ 200MG BASE TABLET / ORAL RLD, RS 2012-06-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N201803-001 ADVIL EQ 200MG BASE TABLET / ORAL RLD, RS 2012-06-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N201803-001 ADVIL EQ 200MG BASE TABLET / ORAL RLD, RS 2012-06-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N201803-001 ADVIL EQ 200MG BASE TABLET / ORAL RLD, RS 2012-06-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N201803-001 ADVIL EQ 200MG BASE TABLET / ORAL RLD, RS 2012-06-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N201803-001 ADVIL EQ 200MG BASE TABLET / ORAL RLD, RS 2012-06-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N201803-001 ADVIL EQ 200MG BASE TABLET / ORAL RLD, RS 2012-06-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N201803-001 ADVIL EQ 200MG BASE TABLET / ORAL RLD, RS 2012-06-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N201803-001 ADVIL EQ 200MG BASE TABLET / ORAL RLD, RS 2012-06-12 e64feba35796…
Additional Listing Data#
Finished product Yes
Brand name base Advil
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IBUPROFEN SODIUM 256 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination RM1CE97Z4N Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 153008 Internal RxNorm lookup 310965 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0573-0134-20 Advil 1 in 1 CARTON TABLET, COATED 1 20 0573-0134-20 Advil 20 in 1 BOTTLE TABLET, COATED 20 20 0573-0134-80 Advil 1 in 1 CARTON TABLET, COATED 1 20 0573-0134-80 Advil 80 in 1 BOTTLE TABLET, COATED 80 20
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded IBUPROFEN SODIUM ACTIVE INGREDIENT RM1CE97Z4N ADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 9 IBUPROFEN ACTIVE MOIETY WK2XYI10QM ADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 9 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 ADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 9 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ ADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 9 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 9 COPOVIDONE K25-31 INACTIVE INGREDIENT D9C330MD8B ADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 9 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 9 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 9 MANNITOL INACTIVE INGREDIENT 3OWL53L36A ADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 9 MEDIUM-CHAIN TRIGLYCERIDES INACTIVE INGREDIENT C9H2L21V7U ADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 9 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 9 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 9 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 9 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J ADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 9 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 ADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 9 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ADVIL (IBUPROFEN SODIUM) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0573-0134 ADVIL (IBUPROFEN SODIUM) TABLET, COATED [HALEON US HOLDINGS LLC] 19 Current NDC, Legacy NDC, 4 package rows 20240625_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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0573-0134-20 00573013420 1 BOTTLE in 1 CARTON (0573-0134-20) / 20 TABLET, COATED in 1 BOTTLE 1 bottle 2013-07-08 0000-00-00 No No Current 0573-0134-80 00573013480 1 BOTTLE in 1 CARTON (0573-0134-80) / 80 TABLET, COATED in 1 BOTTLE 1 bottle 2013-07-08 0000-00-00 No No Current