Diurex
- Product NDC
- 52389-155
- 11-digit product format
- 523890155
- Labeler code
- 52389
- Product ID
- 52389-155_32c05c2a-5010-0362-e063-6394a90af7cf
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Caffeine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Kobayashi Healthcare International, Inc.
- Application
- M027
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2005-09-01
- Substance
- CAFFEINE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Diurex
- Brand name suffix
- Ultra
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CAFFEINE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3G6A5W338E |
| Rxcui | 308853 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 52389-155-02 | DiurexUltra | 80 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 80 | | 15 |
| 52389-155-02 | DiurexUltra | 2 in 1 PACKAGE | TABLET, FILM COATED | 2 | | 15 |
| 52389-155-80 | DiurexUltra | 80 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 80 | | 15 |
| 52389-155-90 | DiurexUltra | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 15 |
| 52389-155-90 | DiurexUltra | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 15 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Caffeine | ACTIVE INGREDIENT | 3G6A5W338E | DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] | 3 | |
| Caffeine | ACTIVE MOIETY | 3G6A5W338E | DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] | 3 | |
| Acacia | INACTIVE INGREDIENT | 5C5403N26O | DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] | 3 | |
| Calcium carbonate | INACTIVE INGREDIENT | H0G9379FGK | DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] | 3 | |
| Cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] | 3 | |
| Croscarmellose sodium | INACTIVE INGREDIENT | M28OL1HH48 | DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] | 3 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] | 3 | |
| Ethyl vanillin | INACTIVE INGREDIENT | YC9ST449YJ | DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] | 3 | |
| FD&C Blue No. 1 | INACTIVE INGREDIENT | H3R47K3TBD | DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] | 3 | |
| FD&C Blue No. 2 | INACTIVE INGREDIENT | L06K8R7DQK | DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] | 3 | |
| Hypromellose | INACTIVE INGREDIENT | 3NXW29V3WO | DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] | 3 | |
| Lactose | INACTIVE INGREDIENT | J2B2A4N98G | DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] | 3 | |
| Magnesium silicate | INACTIVE INGREDIENT | 9B9691B2N9 | DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] | 3 | |
| Magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] | 3 | |
| Maltodextrin | INACTIVE INGREDIENT | 7CVR7L4A2D | DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] | 3 | |
| Polyethylene glycol 600 | INACTIVE INGREDIENT | NL4J9F21N9 | DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] | 3 | |
| Polysorbate 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] | 3 | |
| Stearic acid | INACTIVE INGREDIENT | 4ELV7Z65AP | DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] | 3 | |
| Titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52389-155 | DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.] | 15 | Current NDC, Legacy NDC, 5 package rows | 20250416_9a035265-40c6-43f5-8de6-6bece8449840.zip |
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 |
|---|
| 52389-155-02 | 52389015502 | 2 BOTTLE, PLASTIC in 1 PACKAGE (52389-155-02) / 80 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | | 2024-01-04 | | No | No | Current |
| 52389-155-80 | 52389015580 | 80 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (52389-155-80) | | 2005-09-01 | 0000-00-00 | No | No | Current |
| 52389-155-90 | 52389015590 | 1 BOTTLE in 1 CARTON (52389-155-90) / 90 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2005-09-01 | 0000-00-00 | No | No | Current |