Acetaminophen
- Product NDC
- 49348-973
- 11-digit product format
- 493480973
- Labeler code
- 49348
- Product ID
- 49348-973_ee9eab9e-ad98-57c2-e053-2a95a90a9531
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Strategic Sourcing Services LLC
- Application
- part343
- Marketing category
- OTC MONOGRAPH NOT FINAL
- Marketing start
- 2012-12-13
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN
- Active strength
- 325 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 49348-973 | D | Discontinued by firm | 2026-10-05 | ||
| excluded package | package | 49348-973 | 49348-973-10 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 49348-973 | 49348-973-16 | D | Discontinued by firm | 2026-10-05 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 49348-973-16 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 49348-973-10 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 49348-973-16 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 49348-973-16 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 49348-973-16 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 49348-973-16 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 49348-973-16 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 49348-973-16 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 49348-973-16 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 49348-973-16 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 49348-973-16 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 49348-973-16 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 49348-973-16 | 557ba5c1ecfa… | 9c80585c8c6e… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49348-973-10 | EA - Each | 49348-973 | 8272bb6e-93f6-4ca2-82ca-97ae0df96841 | 1 | 2014-05-02 |
| 49348-973-16 | EA - Each | 49348-973 | 57cf5560-9dba-42c7-a98c-cb509a1d3150 | 1 | 2017-10-13 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Acetaminophen | ACTIVE INGREDIENT | 362O9ITL9D | ACETAMINOPHEN TABLET, COATED [MCKESSON] | 1 | |
| Acetaminophen | ACTIVE MOIETY | 362O9ITL9D | ACETAMINOPHEN TABLET, COATED [MCKESSON] | 1 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | ACETAMINOPHEN TABLET, COATED [MCKESSON] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A CORN | INACTIVE INGREDIENT | AG9B65PV6B | ACETAMINOPHEN TABLET, COATED [MCKESSON] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | ACETAMINOPHEN TABLET, COATED [MCKESSON] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | ACETAMINOPHEN TABLET, COATED [MCKESSON] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 313782 | acetaminophen 325 MG Oral Tablet | PSN | ba4b33b3-e071-4b03-88a0-89dc85f61625 | 1 |
| 313782 | acetaminophen 325 MG Oral Tablet | SCD | ba4b33b3-e071-4b03-88a0-89dc85f61625 | 1 |
| 313782 | APAP 325 MG Oral Tablet | SY | ba4b33b3-e071-4b03-88a0-89dc85f61625 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 49348-973-10 | 49348097310 | 1 BOTTLE, PLASTIC in 1 CARTON (49348-973-10) > 100 TABLET, COATED in 1 BOTTLE, PLASTIC | 2017-09-01 | 0000-00-00 | No | No | Current |
| 49348-973-16 | 49348097316 | 1000 TABLET, COATED in 1 BOTTLE, PLASTIC (49348-973-16) | 2017-06-01 | 0000-00-00 | No | No | Current |