BackAid
- Product NDC
- 52389-253
- 11-digit product format
- 523890253
- Labeler code
- 52389
- Product ID
- 52389-253_41aea851-bb73-0113-e063-6294a90a245f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen, caffeine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Kobayashi Healthcare International, Inc.
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-10-31
- Substance
- ACETAMINOPHEN; CAFFEINE
- Active strength
- 500; 75 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BackAid
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 500 mg/1 |
| CAFFEINE | 75 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, 3G6A5W338E |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 52389-253-14 | BackAid | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 2 |
| 52389-253-14 | BackAid | 14 in 1 BLISTER PACK | TABLET, FILM COATED | 14 | | 2 |
| 52389-253-28 | BackAid | 2 in 1 CARTON | TABLET, FILM COATED | 2 | | 2 |
| 52389-253-28 | BackAid | 14 in 1 BLISTER PACK | TABLET, FILM COATED | 14 | | 2 |
| 52389-253-38 | BackAid | 38 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 38 | | 2 |
| 52389-253-38 | BackAid | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52389-253 | BACKAID (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.] | 1 | Current NDC, 6 package rows | 20241211_25db6bb5-96b6-4be1-e063-6294a90a2300.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 52389-253-14 | 52389025314 | 1 BLISTER PACK in 1 CARTON (52389-253-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2024-12-11 | No | No | Current |
| 52389-253-28 | 52389025328 | 2 BLISTER PACK in 1 CARTON (52389-253-28) / 14 TABLET, FILM COATED in 1 BLISTER PACK | 2 blister pack | 2024-12-11 | No | No | Current |
| 52389-253-38 | 52389025338 | 1 BOTTLE, PLASTIC in 1 CARTON (52389-253-38) / 38 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | | 2024-12-11 | No | No | Current |