Children Acetaminophen Oral Solution
- Product NDC
- 0904-7014
- 11-digit product format
- 009047014
- Labeler code
- 0904
- Product ID
- 0904-7014_372893a0-1ef9-1c7c-e063-6294a90a6181
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- MAJOR PHARMACEUTICALS
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-10-01
- Substance
- ACETAMINOPHEN
- Active strength
- 160 mg/5mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Children Acetaminophen Oral Solution
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 160 mg/5mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 362O9ITL9D |
| Rxcui | 307675 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0904-7014-16 | 2021-03-15 | C162847 | 48780-1 | ba0f9c33-530c-a910-e053-dadaa90a0b85 | Major- APAP Child Sol 7014 |
| 0904-7014-20 | 2021-03-15 | C162847 | 48780-1 | ba0f9c33-530c-a910-e053-dadaa90a0b85 | Major- APAP Child Sol 7014 |
| 0904-7014-16 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-530c-a910-e053-dadaa90a0b85 | Major- APAP Child Sol 7014 |
| 0904-7014-20 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-530c-a910-e053-dadaa90a0b85 | Major- APAP Child Sol 7014 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0904-7014-16 | Children Acetaminophen Oral Solution | 473 mL in 1 BOTTLE | LIQUID | 473 | 7 | |
| 0904-7014-20 | Children Acetaminophen Oral Solution | 118 mL in 1 BOTTLE | LIQUID | 118 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-7014-16 | ML - Milliliter | 0904-7014 | fde87ac6-229a-4749-8cae-65366a4b0e4f | 1 | 2019-11-12 |
| 0904-7014-20 | ML - Milliliter | 0904-7014 | a0a63714-8c01-42e1-ade2-5f84780549ab | 1 | 2019-11-12 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 307675 | acetaminophen 160 MG in 5 mL Oral Solution | PSN | cfca5147-f390-40bd-8f13-c5b3b8d1c5b0 | 7 |
| 307675 | acetaminophen 32 MG/ML Oral Solution | SCD | cfca5147-f390-40bd-8f13-c5b3b8d1c5b0 | 7 |
| 307675 | acetaminophen 160 MG per 5 ML Oral Solution | SY | cfca5147-f390-40bd-8f13-c5b3b8d1c5b0 | 7 |
| 307675 | acetaminophen 325 MG per 10.15 ML Oral Solution | SY | cfca5147-f390-40bd-8f13-c5b3b8d1c5b0 | 7 |
| 307675 | acetaminophen 650 MG per 20.3 ML Oral Solution | SY | cfca5147-f390-40bd-8f13-c5b3b8d1c5b0 | 7 |
| 307675 | acetaminophen 80 MG per 2.5 ML Oral Solution | SY | cfca5147-f390-40bd-8f13-c5b3b8d1c5b0 | 7 |
| 307675 | APAP 32 MG/ML Oral Solution | SY | cfca5147-f390-40bd-8f13-c5b3b8d1c5b0 | 7 |
| 307675 | acetaminophen 160 MG in 5 mL Oral Solution | PSN | bda0d08a-042d-4430-bd88-1a44f607b71c | 3 |
| 307675 | acetaminophen 32 MG/ML Oral Solution | SCD | bda0d08a-042d-4430-bd88-1a44f607b71c | 3 |
| 307675 | acetaminophen 160 MG per 5 ML Oral Solution | SY | bda0d08a-042d-4430-bd88-1a44f607b71c | 3 |
| 307675 | acetaminophen 325 MG per 10.15 ML Oral Solution | SY | bda0d08a-042d-4430-bd88-1a44f607b71c | 3 |
| 307675 | acetaminophen 650 MG per 20.3 ML Oral Solution | SY | bda0d08a-042d-4430-bd88-1a44f607b71c | 3 |
| 307675 | acetaminophen 80 MG per 2.5 ML Oral Solution | SY | bda0d08a-042d-4430-bd88-1a44f607b71c | 3 |
| 307675 | APAP 32 MG/ML Oral Solution | SY | bda0d08a-042d-4430-bd88-1a44f607b71c | 3 |
| 307675 | acetaminophen 160 MG in 5 mL Oral Solution | PSN | 42a17f54-7851-84fb-e063-6394a90a9ec1 | 1 |
| 307675 | acetaminophen 32 MG/ML Oral Solution | SCD | 42a17f54-7851-84fb-e063-6394a90a9ec1 | 1 |
| 307675 | acetaminophen 160 MG per 5 ML Oral Solution | SY | 42a17f54-7851-84fb-e063-6394a90a9ec1 | 1 |
| 307675 | acetaminophen 325 MG per 10.15 ML Oral Solution | SY | 42a17f54-7851-84fb-e063-6394a90a9ec1 | 1 |
| 307675 | acetaminophen 650 MG per 20.3 ML Oral Solution | SY | 42a17f54-7851-84fb-e063-6394a90a9ec1 | 1 |
| 307675 | acetaminophen 80 MG per 2.5 ML Oral Solution | SY | 42a17f54-7851-84fb-e063-6394a90a9ec1 | 1 |
| 307675 | APAP 32 MG/ML Oral Solution | SY | 42a17f54-7851-84fb-e063-6394a90a9ec1 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0904-7014-16 | 00904701416 | 473 mL in 1 BOTTLE (0904-7014-16) | 473 ml | 2019-10-01 | 0000-00-00 | No | No | Current |
| 0904-7014-20 | 00904701420 | 118 mL in 1 BOTTLE (0904-7014-20) | 118 ml | 2019-10-01 | 0000-00-00 | No | No | Current |