SafeTynadol
- Product NDC
- 81389-001
- 11-digit product format
- 813890001
- Labeler code
- 81389
- Product ID
- 81389-001_08c11030-7b99-55ae-e063-6394a90a1437
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Sinew Pharma Inc.
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-01-21
- Substance
- ACETAMINOPHEN
- Active strength
- 500 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SafeTynadol
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 500 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 198440 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| b956d527-7ea7-e084-e053-2a95a90a866d | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 81389-001-01 | SafeTynadol | 200 in 1 BOTTLE | TABLET, COATED | 200 | 3 |
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| NIGHT-TIME MULTI-SYMPTOM COLD/FLU Original | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | DeMoulas Market Basket | eb24323f-82a1-4ba3-9359-fe81571c3fba | 2023-12-29 | Warnings | M013 |
| Nite-TimeCOLD/FLU CHERRY COLD/FLU CHERRY | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Salado Sales, Inc. | e6c3e545-b2ad-47f0-8318-c134a8e24f5b | 2023-12-29 | Warnings | M013 |
| Daytime Non-Drowsy COLD/FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Salado Sales, Inc. | e181b371-78c7-4163-865d-acc064be33ca | 2023-12-29 | Warnings | M013 |
| Childrens Pain and Fever Cherry flavor | ACETAMINOPHEN | Walgreen Company | 64c65244-f7a3-401b-b83a-bf66d45268e2 | 2023-12-29 | Warnings | M013 |
| Nite-Time COLD/FLU ORIGINAL | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Salado Sales, Inc. | fcd24753-b42b-4d05-8379-0ec0351ab217 | 2023-12-29 | Warnings | M013 |
| NIGHT-TIME MULTI-SYMPTOM COLD/FLU Cherry | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | DeMoulas Market Basket | e772cdf5-d01d-4752-8cfb-7e7f4d7a8dd0 | 2023-12-29 | Warnings | M013 |
| Childrens Pain and Fever, Grape flavor | ACETAMINOPHEN | Walgreen Company | 0995d69f-61aa-40b0-b095-bb8595caf773 | 2023-12-29 | Warnings | M013 |
| DAY-TIME Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | DeMoulas Market Basket | ce900e42-d0c8-408d-a1c3-3a9bef1c97ee | 2023-12-29 | Warnings | M013 |
| Pain Relief PM | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | DOLGENCORP, INC. | 06553550-5685-f3c3-e063-6394a90aef07 | 2023-12-22 | Warnings | M013 |
| Tension Headache Pain Relieving Aid | ACETAMINOPHEN,CAFFEINE | WAL-MART STORES INC | 00fadd26-a6eb-dc5e-e063-6394a90a3cca | 2023-12-15 | Warnings | M013 |
| Dye-Free Aspirin 81 | ASPIRIN | WALGREENS | d71a9d3a-cd28-14a8-e053-2995a90a832b | 2023-12-15 | Warnings | M013 |
| Lil Drug Store Aspirin 325 | ASPIRIN | Lil Drug Store Products, Inc | de59aae2-f794-4243-acc8-37a10e27abde | 2023-12-15 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN TABLET, EXTRA STRENGTH | Lil' Drug Store Products, Inc. | f0fdab5a-9d07-57aa-e053-2a95a90adc7f | 2023-12-15 | Warnings | M013 |
| BC Cherry | ASPIRIN AND CAFFEINE | Lil' Drug Store Products, Inc | 79ea721b-d656-44f7-9d13-390debee7be0 | 2023-12-15 | Warnings | M013 |
| Alka-Seltzer | BUFFERED ASPIRIN | Lil' Drug Store Products, Inc. | 0c7a60e7-0bde-9aa2-e063-6294a90a3209 | 2023-12-14 | Warnings | M013 |
| Circle K Aspirin 325 | ASPIRIN | Lil Drug Store Products, Inc | 4cd306e3-2119-4272-9da4-a848fe2746fa | 2023-12-14 | Warnings | M013 |
| Circle K Pain Reliever Extra Strength | ACETAMINOPHEN | Lil' Drug Store Products, Inc. | f2359bc3-901f-4ecb-b402-cb2fe404a935 | 2023-12-14 | Warnings | M013 |
| Childrens Pain Relief | ACETAMINOPHEN | DISCOUNT DRUG MART | c55b8f9d-1396-43c0-acc9-5e3485eadb07 | 2023-12-08 | Warnings | M013 |
| Childrens Pain Relief | ACETAMINOPHEN | DISCOUNT DRUG MART | 775519ad-5683-451f-9bfc-5fafc70c68ec | 2023-12-08 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | WALGREEN CO. | c20c814b-35f5-4c46-e053-2a95a90a50f2 | 2023-12-08 | Warnings | M013 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198440 | acetaminophen 500 MG Oral Tablet | PSN | b956d527-7ea7-e084-e053-2a95a90a866d | 3 |
| 198440 | acetaminophen 500 MG Oral Tablet | SCD | b956d527-7ea7-e084-e053-2a95a90a866d | 3 |
| 198440 | APAP 500 MG Oral Tablet | SY | b956d527-7ea7-e084-e053-2a95a90a866d | 3 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 81389-001-01 | 81389000101 | 200 TABLET, COATED in 1 BOTTLE (81389-001-01) | 2021-01-21 | 0000-00-00 | No | No | Current |