NDC 11822-0789OTC monographFDA ANDA · ANDA090397

Ibuprofen, diphenhydramine HCl

Active substance: Ibuprofen, diphenhydramine HCl

FDA labeler: Rite Aid Corporation

3 formulations • 7 package configurations
All 10 registered NDCs — click to copy
In one line

Ibuprofen, diphenhydramine HCl (Ibuprofen, diphenhydramine HCl) NDC 11822-0789 converts to 11822-0789-04 for billing. It is dispensed by a pharmacy and billed directly on the NDC — no HCPCS J-code is required.

openFDA Live Registry SyncHIPAA 5-4-2 StandardCMS Level II Crosswalk
Listing: 11822-0789
Billing & reimbursement crosswalk

NDC • HCPCS Level II • CPT administration

Reimbursement channel
NDC direct
Oral / Topical formulation billed directly via 11-Digit NDC (No HCPCS J-Code required).
Standard pharmacy claim — no J-Code required
11-digit HIPAA NDC
11822-0789-04
Zero-padded 5-4-2 format
Standard conversion
CPT administration code
Self-Administered (Oral)
Dispensed via retail/mail pharmacy. No clinical administration procedure (CPT) required.
UB-04 revenue code
Rev 0250
0250 (General Pharmacy)
Qualifier: ML
Complete drug registry

All registered strengths & packaging

Every registered strength and package for IBUPROFEN, DIPHENHYDRAMINE HCL, with 10-digit and 11-digit NDC formats
Formulation / rolePackage NDCProduct NDC11-digit HIPAAPackaging detailCopy
200 mg/1, 25 mg/111822-0789-411822-078911822-0789-041 BOTTLE in 1 CARTON (11822-0789-4) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE
200 mg/1, 25 mg/111673-225-1511673-22511673-0225-151 BOTTLE in 1 CARTON (11673-225-15) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE
200 mg/1, 25 mg/169452-205-0469452-20569452-0205-041 BLISTER PACK in 1 CARTON (69452-205-04) / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
200 mg/1, 25 mg/169452-205-1169452-20569452-0205-1120 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-205-11)
200 mg/1, 25 mg/169452-205-1569452-20569452-0205-1540 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-205-15)
200 mg/1, 25 mg/169452-205-2069452-20569452-0205-20100 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-205-20)
200 mg/1, 25 mg/169452-205-7869452-20569452-0205-7880 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-205-78)
FDA drug label

Prescribing information

Taken from the manufacturer's FDA Structured Product Labeling submission. This is the label as filed, not a summary.

3 Label Sections
Uses ■ for relief of occasional sleeplessness when associated with minor aches and pains ■ helps you fall asleep and stay asleep
Directions ■ do not take more than directed ■ adults and children 12 years and over: take 2 capsules at bedtime ■ do not take more than 2 capsules in 24 hours
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. Do not use ■ if you have ever had an allergic reaction to any other pain reliever/fever reducer ■ unless you have time for a full night’s sleep ■ in children under 12 years of age ■ right before or after heart surgery ■ with any other product containing diphenhydramine, even one used on skin ■ if you have sleeplessness without pain Ask a doctor before use if ■ stomach bleeding warning applies to you ■ you have problems or serious side effects from taking pain relievers or fever reducers ■ you have a history of stomach problems, such as heartburn ■ you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke ■ you are taking a diuretic ■ you have a breathing problem such as emphysema or chronic bronchitis ■ you have glaucoma ■ you have trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are ■ taking sedatives or tranquilizers, or any other sleep-aid ■ under a doctor's care for any continuing medical illness ■ taking any other antihistamines ■ taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin ■ taking any other drug When using this product ■ drowsiness will occur ■ avoid alcoholic drinks ■ do not drive a motor vehicle or operate machinery ■ take with food or milk if stomach upset occurs Stop use and ask a doctor if ■ you experience any of the following signs of stomach bleeding: ■ feel faint ■ vomit blood ■ have bloody or black stools ■ have stomach pain that does not get better ■ you have symptoms of heart problems or stroke: ■ chest pain ■ trouble breathing ■ weakness in one part or side of body ■ slurred speech ■ leg swelling ■ pain gets worse or lasts more than 10 days ■ sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness ■ redness or swelling is present in the painful area ■ any new symptoms appear If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
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