Tylenol Extra Strength
- Product NDC
- 67751-167
- 11-digit product format
- 677510167
- Labeler code
- 67751
- Product ID
- 67751-167_2385e645-881c-5dd8-e063-6394a90adfab
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Navajo Manufacturing Company Inc.
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2016-09-22
- Substance
- ACETAMINOPHEN
- Active strength
- 500 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 package | package | 67751-167 | 67751-167-04 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 67751-167 | 67751-167-03 | 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 |
|---|---|---|---|---|---|
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 67751-167-03 | 1332a3947898… | d4bfe170f9cd… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 67751-167-02 | 1332a3947898… | d4bfe170f9cd… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 67751-167-04 | 1332a3947898… | d4bfe170f9cd… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 67751-167-01 | 1332a3947898… | d4bfe170f9cd… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 67751-167-01 | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 67751-167-04 | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 67751-167-03 | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 67751-167-02 | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 67751-167-01 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 67751-167-04 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 67751-167-03 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 67751-167-02 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 67751-167-01 | bd6a592717d7… | 303034d00443… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 67751-167-04 | bd6a592717d7… | 303034d00443… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 67751-167-03 | bd6a592717d7… | 303034d00443… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 67751-167-02 | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 67751-167-03 | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 67751-167-03 | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 67751-167-03 | 9bebd1f3094a… | 5416666fcb17… |
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
- Tylenol Extra Strength
- 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#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 86b6ac01-3866-4cd8-a1be-9babb6ff311b | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Indexing SPL | Related label |
|---|---|---|---|
| 67751-167-01 | 2024-04-17 | d6a99b39-4b62-a426-e053-dadaa90af4c2 | Tylenol Extra Strength |
| 67751-167-02 | 2024-04-17 | d6a99b39-4b62-a426-e053-dadaa90af4c2 | Tylenol Extra Strength |
| 67751-167-03 | 2024-04-17 | 9d75b9cf-e68d-f424-e053-dadaa90a57ce | Tylenol Extra Strength |
| 67751-167-04 | 2024-04-17 | d6a99b39-4b62-a426-e053-dadaa90af4c2 | Tylenol Extra Strength |
| 67751-167-01 | 2022-01-28 | d6a99b39-4b62-a426-e053-dadaa90af4c2 | Tylenol Extra Strength |
| 67751-167-02 | 2022-01-28 | d6a99b39-4b62-a426-e053-dadaa90af4c2 | Tylenol Extra Strength |
| 67751-167-04 | 2022-01-28 | d6a99b39-4b62-a426-e053-dadaa90af4c2 | Tylenol Extra Strength |
| 67751-167-03 | 2020-01-31 | 9d75b9cf-e68d-f424-e053-dadaa90a57ce | Tylenol Extra Strength |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67751-167-01 | Tylenol Extra Strength | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 6 | |
| 67751-167-01 | Tylenol Extra Strength | 2 in 1 POUCH | TABLET, FILM COATED | 2 | 6 | |
| 67751-167-02 | Tylenol Extra Strength | 4 in 1 POUCH | TABLET, FILM COATED | 4 | 6 | |
| 67751-167-02 | Tylenol Extra Strength | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 6 | |
| 67751-167-04 | Tylenol Extra Strength | 12 in 1 TRAY | TABLET, FILM COATED | 12 | 6 | |
| 67751-167-04 | Tylenol Extra Strength | 1 in 1 POUCH | TABLET, FILM COATED | 1 | 6 | |
| 67751-167-03 | Tylenol Extra Strength | 12 in 1 TRAY | TABLET, FILM COATED | 12 | 2 | |
| 67751-167-03 | Tylenol Extra Strength | 2 in 1 POUCH | TABLET, FILM COATED | 2 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 67751-167 | TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [NAVAJO MANUFACTURING COMPANY INC.] | 6 | Current NDC, Legacy NDC, 6 package rows | 20241004_86b6ac01-3866-4cd8-a1be-9babb6ff311b.zip |
| 67751-167 | TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [NAVAJO MANUFACTURING COMPANY INC.] | 2 | Current NDC, Legacy NDC, 2 package rows | 20240418_65bf1556-f25a-9439-e053-2a91aa0a3194.zip |
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 |
|---|---|---|---|---|---|---|
| Childrens TYLENOL | ACETAMINOPHEN | Kenvue Brands LLC | 79669930-f744-4bb1-8325-b75951489b64 | 2025-09-17 | Warnings | M013 |
| childrens acetaminophen | ACETAMINOPHEN | United Natural Foods, Inc. dba UNFI | f4642725-f953-4aa8-8106-f468d8220f65 | 2025-09-17 | Warnings | M013 |
| Pain and Fever Childrens | ACETAMINOPHEN | Wal-Mart Stores Inc | 462580aa-712d-43bb-846d-631db3e79c1d | 2025-09-16 | Warnings | M013 |
| Pain and Fever Childrens | ACETAMINOPHEN | Wal-Mart Stores Inc | 1729d4b1-ca3b-4360-8328-2484f239440a | 2025-09-15 | Warnings | M013 |
| Pain Reliever PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | L.N.K. International, Inc. | ff199db8-c7ea-4b6e-ad8b-3ceeca883d92 | 2025-09-15 | Warnings | M013 |
| Acetaminophen PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | FOODHOLD U.S.A., LLC | fdd7ce80-d6be-41b9-affd-d024cf306b50 | 2025-09-12 | Warnings | M013 |
| Acetaminophen PM | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | COSTCO WHOLESALE CORPORATION | e03dfa65-1a9c-4284-89cf-19ccbaabfa32 | 2025-09-12 | Warnings | M013 |
| Extra Strength Pain Reliever | ACETAMINOPHEN | INGLES MARKETS, INC. | 3e89240b-0e27-fde4-e063-6394a90a779f | 2025-09-11 | Warnings | M013 |
| Extra Strength Pain Reliever | ACETAMINOPHEN | INGLES MARKETS, INC. | 10e4bbe2-a47e-ff16-e063-6294a90a56a1 | 2025-09-11 | Warnings | M013 |
| Back and Body Extra Strength | ASPIRIN, CAFFEINE | L.N.K. International, Inc. | 6d254f3f-8223-4a6e-a3b2-f53f145ff3dc | 2025-09-11 | Warnings | M013 |
| Aspirin 81 mg Low Dose | ASPIRIN | HEB | 926fe7b6-9607-469f-912f-4019891067a9 | 2025-09-10 | Warnings | M013 |
| Bayer Genuine Aspirin | ASPIRIN | Unifirst First Aid Corporation | 356e4ff4-a7f1-4a50-9b86-2555e232b300 | 2025-09-09 | Warnings | M013 |
| Medique at Home Aspirin | ASPIRIN | Unifirst First Aid Corporation | b5a469c1-9ab4-5bd7-e053-2995a90a86d1 | 2025-09-09 | Warnings | M013 |
| Medique Products Aspirin | ASPIRIN | Unifirst First Aid Corporation | 9b28fed0-a993-ca72-e053-2995a90ac7fd | 2025-09-09 | Warnings | M013 |
| Unishield Aspirin | ASPIRIN | Unishield | ba106b20-32ac-df90-e053-2995a90adaef | 2025-09-09 | Warnings | M013 |
| Medi First Pain Ache | ASPIRIN,CAFFEINE | Unifirst First Aid Corporation | e82d02d5-3e44-a8f8-e053-2a95a90a2688 | 2025-09-09 | Warnings | M013 |
| Medique at Home Back Pain Relief | MAGNESIUM SALICYLATE | Unifirst First Aid Corporation | e56c4aef-fa0b-74db-e053-2a95a90a9745 | 2025-09-09 | Warnings | M013 |
| Travel Savvy Aspirin | ASPIRIN | Bellegrove Medical Supply, Inc. | bae80044-ad7f-3bf5-e053-2995a90a42f9 | 2025-09-09 | Warnings | M013 |
| McKesson Aspirin | ASPIRIN | McKesson Medical-Surgical | dabd741e-e11c-52c1-e053-2a95a90a91d5 | 2025-09-09 | Warnings | M013 |
| Travel Savvy Non-Aspirin | ACETAMINOPHEN 325MG | Bellegrove Medical Supply, Inc. | 6ab08633-5d5a-42b2-e053-2991aa0ab41a | 2025-09-09 | Warnings | M013 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 67751-167-01 | 67751016701 | 1 POUCH in 1 CARTON (67751-167-01) / 2 TABLET, FILM COATED in 1 POUCH | 1 pouch | 2016-09-22 | 0000-00-00 | No | No | Current |
| 67751-167-02 | 67751016702 | 1 POUCH in 1 CARTON (67751-167-02) / 4 TABLET, FILM COATED in 1 POUCH | 1 pouch | 2016-09-22 | 0000-00-00 | No | No | Current |
| 67751-167-03 | 67751016703 | 12 in 1 TRAY | Historical | |||||
| 67751-167-04 | 67751016704 | 12 POUCH in 1 TRAY (67751-167-04) > 1 TABLET, FILM COATED in 1 POUCH | 12 pouch | 2016-09-22 | 0000-00-00 | No | No | Current |