Indications and uses
for relief of occasional sleeplessness when associated with minor aches and pains helps you fall asleep and stay asleep
for relief of occasional sleeplessness when associated with minor aches and pains helps you fall asleep and stay asleep
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 Other information • each capsule contains: potassium 20 mg • read all warnings and directions before use. Keep carton. • store at 20-25°C (68-77°F) • avoid excessive heat above 40°C (104°F) • protect from light
Active ingredients (in each capsule) Purposes
Diphenhydramine hydrochloride 25 mg…………………………………...Nighttime sleep-aid
Solubilized ibuprofen equal to ibuprofen 200 mg (NSAID)*……………...Pain reliever
(present as the free acid and potassium salt)
*nonsteroidal anti-inflammatory drug
Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
If an allergic reaction occurs, stop use and seek medical help right away.
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
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.
• 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
ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in 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.
Other information
• each capsule contains: potassium 20 mg
• read all warnings and directions before use. Keep carton.
• store at 20-25°C (68-77°F)
• avoid excessive heat above 40°C (104°F)
• protect from light
Anidrisorb, D&C red no. 33, FD&C blue no. 1, gelatin, Hydrolyzed gelatin, medium chain triglyceride. Opacode white ink, Polyethylene glycol 600, potassium hydroxide, purified water.
Ingredients of Opacode white ink: shellac glaze in ethanol, titanium dioxide, n-butyl alcohol, lecithin (soya), simethicone and purified water.
Call at 1877 244 9825
Manufactured by:
Strides Pharma Science Limited
Bengaluru - 562106, India
Distributed by:
Strides Pharma Inc.
East Brunswick, NJ 08816
Revised: 01/2022
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | ACTIVE INGREDIENT | TC2D6JAD40 | 2 | |
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | 2 | |
| DIPHENHYDRAMINE | ACTIVE MOIETY | 8GTS82S83M | 2 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | 2 | |
| BUTYL ALCOHOL | INACTIVE INGREDIENT | 8PJ61P6TS3 | 2 | |
| D&C RED NO. 33 | INACTIVE INGREDIENT | 9DBA0SBB0L | 2 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 2 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | 2 | |
| LECITHIN, SOYBEAN | INACTIVE INGREDIENT | 1DI56QDM62 | 2 | |
| MEDIUM-CHAIN TRIGLYCERIDES | INACTIVE INGREDIENT | C9H2L21V7U | 2 | |
| POLYETHYLENE GLYCOL 600 | INACTIVE INGREDIENT | NL4J9F21N9 | 2 | |
| POTASSIUM HYDROXIDE | INACTIVE INGREDIENT | WZH3C48M4T | 2 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | 2 | |
| SORBITAN | INACTIVE INGREDIENT | 6O92ICV9RU | 2 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 64380-732 | 64380-732-14, 64380-732-15, 64380-732-19, 64380-732-20, 64380-732-29, 64380-732-12, 64380-732-13, 64380-732-11, 64380-732-18, 64380-732-92 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | TC2D6JAD40 | ACTIB |
| IBUPROFEN | WK2XYI10QM | ACTIB |
| D&C RED NO. 33 | 9DBA0SBB0L | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| GELATIN | 2G86QN327L | IACT |
| MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | IACT |
| POTASSIUM HYDROXIDE | WZH3C48M4T | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITAN | 6O92ICV9RU | IACT |
| SORBITOL | 506T60A25R | IACT |
| POLYETHYLENE GLYCOL 600 | NL4J9F21N9 | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| POTASSIUM HYDROXIDE | POTASSIUM HYDROXIDE | WZH3C48M4T | CREAM / TOPICAL | 0.5 %w/w | ||
| GELATIN | GELATIN | 2G86QN327L | WAFER / ORAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 24 mg | ||
| GELATIN | GELATIN | 2G86QN327L | SYRUP / ORAL | NA | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION / OPHTHALMIC | 6 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SYRUP / ORAL | 4370 mg/5ml | ||
| SHELLAC | SHELLAC | 46N107B71O | TABLET, EXTENDED RELEASE / ORAL | 213.24 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CREAM / TOPICAL | 80 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | CREAM, AUGMENTED / TOPICAL | 15 %w/w | ||
| BUTYL ALCOHOL | BUTYL ALCOHOL | 8PJ61P6TS3 | CAPSULE / ORAL | 0.02 mg | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | TABLET, EXTENDED RELEASE / ORAL | 20 mg | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE / ORAL | 10932 mg | ||
| SHELLAC | SHELLAC | 46N107B71O | FILM / SUBLINGUAL | NA | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | CAPSULE / ORAL | 4771 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | INJECTION, EMULSION / INTRAVENOUS | 1.1 %w/v | ||
| POLYETHYLENE GLYCOL 600 | POLYETHYLENE GLYCOL 600 | NL4J9F21N9 | TABLET, EXTENDED RELEASE / ORAL | 2.5 mg | ||
| POLYETHYLENE GLYCOL 600 | POLYETHYLENE GLYCOL 600 | NL4J9F21N9 | INJECTION, SOLUTION / INTRAVENOUS | 5 %w/v | ||
| POTASSIUM HYDROXIDE | POTASSIUM HYDROXIDE | WZH3C48M4T | CAPSULE, LIQUID FILLED / ORAL | 154 mg | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET / PERIODONTAL | 3.44 mg | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | AEROSOL, METERED / RESPIRATORY (INHALATION) | 0.1 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, DELAYED RELEASE / ORAL | 55 mg | ||
| SHELLAC | SHELLAC | 46N107B71O | CAPSULE / ORAL | 34.48 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, EXTENDED RELEASE / ORAL | 4 mg | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | CREAM / VAGINAL | 1 %w/w | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | TABLET, FILM COATED / ORAL | 0.33 mg | ||
| BUTYL ALCOHOL | BUTYL ALCOHOL | 8PJ61P6TS3 | CAPSULE, EXTENDED RELEASE / ORAL | 0.01 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUSPENSION / ORAL | 113 mg | ||
| D&C RED NO. 33 | D&C RED NO. 33 | 9DBA0SBB0L | SUSPENSION / ORAL | 0.13 mg/5ml | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | OINTMENT / TOPICAL | 20 %w/w | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | POWDER / SUBLINGUAL | 2 mg | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET, EXTENDED RELEASE / ORAL | 239 mg | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR | 1 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | LOTION / TOPICAL | 10.7 %w/w | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | POWDER, FOR SOLUTION / ORAL | 0.04 mg/5ml | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, EXTENDED RELEASE / ORAL | 428 mg | ||
| POLYETHYLENE GLYCOL 600 | POLYETHYLENE GLYCOL 600 | NL4J9F21N9 | CAPSULE / ORAL | 1742 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / INTRAMUSCULAR | NA | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, CHEWABLE / ORAL | 3555 mg | ||
| GELATIN | GELATIN | 2G86QN327L | DROPS / ORAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, EXTENDED RELEASE / ORAL | 90 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, DELAYED RELEASE / ORAL | 2 mg | ||
| POTASSIUM HYDROXIDE | POTASSIUM HYDROXIDE | WZH3C48M4T | PASTILLE / ORAL | ADJ PH | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | FILM, EXTENDED RELEASE / TRANSDERMAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GEL / TOPICAL | 0.06 %w/w | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, LIQUID FILLED / ORAL | 0.08 mg | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET / SUBLINGUAL | 19 mg | ||
| SHELLAC | SHELLAC | 46N107B71O | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION / SUBCUTANEOUS | 16 %w/v | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | DROPS / ORAL | NA | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET, DELAYED RELEASE / ORAL | 19 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER, FOR SUSPENSION / ORAL | 297 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / INTRASYNOVIAL | 45 %w/v | ||
| POLYETHYLENE GLYCOL 600 | POLYETHYLENE GLYCOL 600 | NL4J9F21N9 | INJECTION / INTRAVENOUS | 5 %w/v | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | LIQUID / ORAL | NA | ||
| SORBITOL | SORBITOL | 506T60A25R | LIQUID / TOPICAL | 1 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET / ORAL | 232 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | CREAM / TOPICAL | 36.8 %w/w | ||
| D&C RED NO. 33 | D&C RED NO. 33 | 9DBA0SBB0L | SOLUTION / DENTAL | NA | ||
| SHELLAC | SHELLAC | 46N107B71O | TABLET, FILM COATED / ORAL | 4.4 mg | ||
| POLYETHYLENE GLYCOL 600 | POLYETHYLENE GLYCOL 600 | NL4J9F21N9 | TABLET, DELAYED RELEASE / ORAL | 1 mg |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A200888-001 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2012-03-05 | f41ea6bd6efb… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 1377e093-27d5-4207-b3ee-92a3e9218f69 | 10d52858-a55f-4053-aa77-da660556a2ad | 2025-04-04 | Warnings | 10d52858-a55f-4053-aa77-da660556a2ad |
Adverse event summaries are temporarily unavailable. Other product information remains available.