FDA.reportPublic FDA data

ADVIL PM

Product NDC
0573-0167
11-digit product format
005730167
Labeler code
0573
Product ID
0573-0167_7ff3116f-dc72-460c-ac1a-80753f1aeb55
Type
HUMAN OTC DRUG
Nonproprietary name
diphenhydramine HCl, ibuprofen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
NDA021393
Marketing category
NDA
Marketing start
2005-12-20
Substance
DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN
Active strength
25; 200 mg/1; mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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
ADVIL PM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1
IBUPROFEN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM, TC2D6JAD40
Rxcui901814

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
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
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0573-0167-102024-01-31C16284748780-11030e365-2bf0-111a-e063-dadaa90a10e2Drug Facts
0573-0167-182024-01-31C16284748780-11030e365-2bf0-111a-e063-dadaa90a10e2Drug Facts
0573-0167-192024-01-31C16284748780-11030e365-2bf0-111a-e063-dadaa90a10e2Drug Facts
0573-0167-202024-01-31C16284748780-11030e365-2bf0-111a-e063-dadaa90a10e2Drug Facts
0573-0167-212024-01-31C16284748780-11030e365-2bf0-111a-e063-dadaa90a10e2Drug Facts
0573-0167-252024-01-31C16284748780-11030e365-2bf0-111a-e063-dadaa90a10e2Drug Facts
0573-0167-262024-01-31C16284748780-11030e365-2bf0-111a-e063-dadaa90a10e2Drug Facts
0573-0167-422024-01-31C16284748780-11030e365-2bf0-111a-e063-dadaa90a10e2Drug Facts
0573-0167-432024-01-31C16284748780-11030e365-2bf0-111a-e063-dadaa90a10e2Drug Facts
0573-0167-442024-01-31C16284748780-11030e365-2bf0-111a-e063-dadaa90a10e2Drug Facts
0573-0167-552024-01-31C16284748780-11030e365-2bf0-111a-e063-dadaa90a10e2Drug Facts
0573-0167-562024-01-31C16284748780-11030e365-2bf0-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-0167-10ADVIL PM1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED121
0573-0167-10ADVIL PM16 in 1 CARTONCAPSULE, LIQUID FILLED1621
0573-0167-18ADVIL PM24 in 1 CARTONCAPSULE, LIQUID FILLED2421
0573-0167-18ADVIL PM1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED121
0573-0167-19ADVIL PM1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED121
0573-0167-19ADVIL PM24 in 1 CARTONCAPSULE, LIQUID FILLED2421
0573-0167-20ADVIL PM32 in 1 CARTONCAPSULE, LIQUID FILLED3221
0573-0167-20ADVIL PM1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED121
0573-0167-21ADVIL PM1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED121
0573-0167-21ADVIL PM40 in 1 CARTONCAPSULE, LIQUID FILLED4021
0573-0167-25ADVIL PM20 in 1 BOTTLECAPSULE, LIQUID FILLED2021
0573-0167-25ADVIL PM1 in 1 CARTONCAPSULE, LIQUID FILLED121
0573-0167-26ADVIL PM30 in 1 BOTTLECAPSULE, LIQUID FILLED3021
0573-0167-26ADVIL PM1 in 1 CARTONCAPSULE, LIQUID FILLED121
0573-0167-42ADVIL PM40 in 1 CARTONCAPSULE, LIQUID FILLED4021
0573-0167-42ADVIL PM1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED121
0573-0167-43ADVIL PM40 in 1 BOTTLECAPSULE, LIQUID FILLED4021
0573-0167-43ADVIL PM1 in 1 CARTONCAPSULE, LIQUID FILLED121
0573-0167-44ADVIL PM1 in 1 CARTONCAPSULE, LIQUID FILLED121
0573-0167-44ADVIL PM50 in 1 BOTTLECAPSULE, LIQUID FILLED5021
0573-0167-55ADVIL PM1 in 1 CARTONCAPSULE, LIQUID FILLED121
0573-0167-55ADVIL PM80 in 1 BOTTLECAPSULE, LIQUID FILLED8021
0573-0167-56ADVIL PM100 in 1 BOTTLECAPSULE, LIQUID FILLED10021
0573-0167-56ADVIL PM1 in 1 CARTONCAPSULE, LIQUID FILLED121

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-0167-10EA - Each0573-0167215fd11c-a5f8-40b6-8e00-0762da413c3c12014-01-04
0573-0167-20EA - Each0573-016702755d54-e1de-4282-b019-343a7ef4ea1212012-07-24
0573-0167-25EA - Each0573-01675c48509c-cd84-4810-846a-2222b554326612015-04-03
0573-0167-43EA - Each0573-016708c315ed-78d2-495c-9542-7e0676410f6a12015-01-05
0573-0167-55EA - Each0573-0167902635c1-b011-4bd5-a3c3-c40426075af012015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40ADVIL PM (DIPHENHYDRAMINE HCL, IBUPROFEN) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE]10
IBUPROFENACTIVE INGREDIENTWK2XYI10QMADVIL PM (DIPHENHYDRAMINE HCL, IBUPROFEN) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE]10
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MADVIL PM (DIPHENHYDRAMINE HCL, IBUPROFEN) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE]10
IBUPROFENACTIVE MOIETYWK2XYI10QMADVIL PM (DIPHENHYDRAMINE HCL, IBUPROFEN) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE]10
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LADVIL PM (DIPHENHYDRAMINE HCL, IBUPROFEN) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE]10
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDADVIL PM (DIPHENHYDRAMINE HCL, IBUPROFEN) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE]10
GELATININACTIVE INGREDIENT2G86QN327LADVIL PM (DIPHENHYDRAMINE HCL, IBUPROFEN) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE]10
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UADVIL PM (DIPHENHYDRAMINE HCL, IBUPROFEN) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE]10
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AADVIL PM (DIPHENHYDRAMINE HCL, IBUPROFEN) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE]10
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TADVIL PM (DIPHENHYDRAMINE HCL, IBUPROFEN) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE]10
SORBITANINACTIVE INGREDIENT6O92ICV9RUADVIL PM (DIPHENHYDRAMINE HCL, IBUPROFEN) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE]10
SORBITOLINACTIVE INGREDIENT506T60A25RADVIL PM (DIPHENHYDRAMINE HCL, IBUPROFEN) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE]10
WATERINACTIVE INGREDIENT059QF0KO0RADVIL PM (DIPHENHYDRAMINE HCL, IBUPROFEN) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-0167ADVIL PM (DIPHENHYDRAMINE HCL, IBUPROFEN) CAPSULE, LIQUID FILLED [HALEON US HOLDINGS LLC]21Current NDC, Legacy NDC, 24 package rows20250117_405afdb4-c157-1d88-f232-848063ba4714.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
901814ibuprofen 200 MG / diphenhydrAMINE HCl 25 MG Oral CapsulePSN405afdb4-c157-1d88-f232-848063ba471421
901814diphenhydramine hydrochloride 25 MG / ibuprofen 200 MG Oral CapsuleSCD405afdb4-c157-1d88-f232-848063ba471421

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0573-0167-10005730167101 in 1 BLISTER PACKHistorical
0573-0167-180057301671824 in 1 CARTONHistorical
0573-0167-19005730167191 in 1 BLISTER PACKHistorical
0573-0167-200057301672032 in 1 CARTONHistorical
0573-0167-21005730167211 in 1 BLISTER PACKHistorical
0573-0167-25005730167251 BOTTLE in 1 CARTON (0573-0167-25) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2005-12-200000-00-00NoNoCurrent
0573-0167-26005730167261 BOTTLE in 1 CARTON (0573-0167-26) / 30 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2005-12-200000-00-00NoNoCurrent
0573-0167-420057301674240 in 1 CARTONHistorical
0573-0167-43005730167431 BOTTLE in 1 CARTON (0573-0167-43) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2005-12-200000-00-00NoNoCurrent
0573-0167-44005730167441 BOTTLE in 1 CARTON (0573-0167-44) / 50 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2005-12-200000-00-00NoNoCurrent
0573-0167-55005730167551 BOTTLE in 1 CARTON (0573-0167-55) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2005-12-200000-00-00NoNoCurrent
0573-0167-56005730167561 BOTTLE in 1 CARTON (0573-0167-56) / 100 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2005-12-200000-00-00NoNoCurrent