Ibuprofen and Pseudoephedrine HCl

Product NDC
69842-092
11-digit product format
698420092
Labeler code
69842
Product ID
69842-092_061cf29a-2116-4ec4-be03-68d22da02b3e
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen and Pseudoephedrine HCl
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
CVS Pharmacy, Inc.
Application
ANDA209235
Marketing category
ANDA
Marketing start
2017-12-01
Substance
IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
200; 30 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], alpha-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209235-001IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEIBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDEEQ 200MG FREE ACID AND POTASSIUM SALT;30MGCAPSULE / ORAL2017-12-01

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ibuprofen and Pseudoephedrine HClIBUPROFEN AND PSEUDOEPHEDRINE HCLCVS Pharmacy, Inc.b8a4d9be-e202-4f99-bece-e2125aaca8b92023-07-14WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1
PSEUDOEPHEDRINE HYDROCHLORIDE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM, 6V9V2RYJ8N
Rxcui1299018

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
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
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61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
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b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-092-13Ibuprofen and Pseudoephedrine HCl4 in 1 CARTONCAPSULE, LIQUID FILLED44
69842-092-13Ibuprofen and Pseudoephedrine HCl8 in 1 BLISTER PACKCAPSULE, LIQUID FILLED84
69842-092-67Ibuprofen and Pseudoephedrine HCl2 in 1 CARTONCAPSULE, LIQUID FILLED24
69842-092-67Ibuprofen and Pseudoephedrine HCl10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69842-092-67EA - Each69842-0922290b24a-6df7-4b81-a9fc-9f56613c237212021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-092IBUPROFEN AND PSEUDOEPHEDRINE HCL CAPSULE, LIQUID FILLED [CVS PHARMACY, INC.]4Current NDC, Legacy NDC, 4 package rows20230716_b8a4d9be-e202-4f99-bece-e2125aaca8b9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1299018ibuprofen 200 MG / pseudoephedrine HCl 30 MG Oral CapsulePSNb8a4d9be-e202-4f99-bece-e2125aaca8b94
1299018ibuprofen 200 MG / pseudoephedrine hydrochloride 30 MG Oral CapsuleSCDb8a4d9be-e202-4f99-bece-e2125aaca8b94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-092-13698420092134 BLISTER PACK in 1 CARTON (69842-092-13) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK4 blister pack2017-12-010000-00-00NoNoCurrent
69842-092-67698420092672 BLISTER PACK in 1 CARTON (69842-092-67) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2017-12-010000-00-00NoNoCurrent