Dolex Fem
- Product NDC
- 55758-326
- 11-digit product format
- 557580326
- Labeler code
- 55758
- Product ID
- 55758-326_4a169436-bb76-aceb-e063-6394a90a557f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Caffeine, Pyrilamine Maleate
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Pharmadel LLC
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2020-10-01
- Substance
- ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE
- Active strength
- 500; 60; 15 mg/1; mg/1; 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dolex Fem
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 500 mg/1 |
| CAFFEINE | 60 mg/1 |
| PYRILAMINE MALEATE | 15 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, 3G6A5W338E, R35D29L3ZA |
| Rxcui | 1597298 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55758-326-02 | Dolex Fem | 2 in 1 PACKET | TABLET, COATED | 2 | | 13 |
| 55758-326-25 | Dolex Fem | 1 in 1 CARTON | TABLET, COATED | 1 | | 13 |
| 55758-326-25 | Dolex Fem | 24 in 1 BLISTER PACK | TABLET, COATED | 24 | | 13 |
| 55758-326-50 | Dolex Fem | 25 in 1 BOX | TABLET, COATED | 25 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55758-326 | DOLEX FEM (ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE) TABLET, COATED [PHARMADEL LLC] | 11 | Current NDC, Legacy NDC, 4 package rows | 20250206_b1cab10b-19f1-f5d5-e053-2995a90a4d5f.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 |
|---|
| 55758-326-02 | 55758032602 | 2 in 1 PACKET | | | | | | Historical |
| 55758-326-24 | 55758032624 | 1 BOTTLE in 1 CARTON (55758-326-24) > 24 TABLET, COATED in 1 BOTTLE | 1 bottle | 2020-10-01 | 0000-00-00 | No | No | Current |
| 55758-326-25 | 55758032625 | 1 BLISTER PACK in 1 CARTON (55758-326-25) / 24 TABLET, COATED in 1 BLISTER PACK | 1 blister pack | 2020-10-01 | 0000-00-00 | No | No | Current |
| 55758-326-50 | 55758032650 | 25 in 1 BOX | | | | | | Historical |