CounterAct
- Product NDC
- 54473-166
- 11-digit product format
- 544730166
- Labeler code
- 54473
- Product ID
- 54473-166_308f1711-b64c-1708-e063-6294a90ad99b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Melaleuca, Inc.
- Application
- ANDA075209
- Marketing category
- ANDA
- Marketing start
- 2023-08-19
- Substance
- LORATADINE
- Active strength
- 10 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- CounterAct
- Brand name suffix
- Allergy
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LORATADINE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7AJO3BO7QN |
| Rxcui | 311372 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 54473-166-32 | CounterActAllergy | 30 in 1 BOTTLE | TABLET | 30 | | 4 |
| 54473-166-32 | CounterActAllergy | 1 in 1 BOX | TABLET | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 54473-166 | COUNTERACT ALLERGY (LORATADINE) TABLET [MELALEUCA, INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20250321_6b5d43ad-a709-4e0b-b91c-36ea0afe7221.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 |
|---|
| 54473-166-30 | 54473016630 | 3 BLISTER PACK in 1 CARTON (54473-166-30) > 10 TABLET in 1 BLISTER PACK | 3 blister pack | 2018-01-01 | 0000-00-00 | No | No | Current |
| 54473-166-32 | 54473016632 | 1 BOTTLE in 1 BOX (54473-166-32) / 30 TABLET in 1 BOTTLE | 1 bottle | 2025-02-28 | | No | No | Current |