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 | 2026-10-12 | |
| excluded package | package | 67751-167 | 67751-167-03 | D | Discontinued by firm | 2026-10-12 |
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 |
|---|---|---|---|---|---|---|
| Pain Relief Extra Strength | ACETAMINOPHEN | Chain Drug Marketing Association | cfaf9495-e654-4dfc-ba23-d2358c3720c4 | 2024-06-13 | Warnings | M013 |
| Aspirin 81 mg Low Dose | ASPIRIN | CHAIN DRUG MARKETING ASSOCIATION, INC. | 18ff2df8-ee65-4219-ad93-cf5090bfac2d | 2024-06-13 | Warnings | M013 |
| Pain Relief Extra Strength | ACETAMINOPHEN | CHAIN DRUG MARKETING ASSOCIATION, INC. | 9fdbaf5e-f88b-4d18-97df-0b2e8dddf377 | 2024-06-13 | Warnings | M013 |
| Aspirin 81 mg Low dose | ASPIRIN | CHAIN DRUG MARKETING ASSOCIATION, INC. | bfb9af64-3195-44bf-bcf3-6b36b40d3cc7 | 2024-06-13 | Warnings | M013 |
| Pain Relief Extra Strength | ACETAMINOPHEN | CHAIN DRUG MARKETING ASSOCIATION, INC. | 1ac7ed71-5afe-d09c-e063-6294a90a3b88 | 2024-06-13 | Warnings | M013 |
| Pain Relief PM Extra Strength | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 3ce5bbf2-d449-464e-abeb-5c26866d1ab5 | 2024-06-13 | Warnings | M013 |
| Aspirin | ASPIRIN | AAA Pharmaceutical, Inc. | 609948d6-0f20-4d0c-adc0-6ae72a4f2b7a | 2024-06-13 | Warnings | M013 |
| Aspirin | ASPIRIN | AAA Pharmaceutical, Inc. | 3f73a359-59d7-47bb-872e-914b0db719af | 2024-06-13 | Warnings | M013 |
| topcare infants pain and fever | ACETAMINOPHEN | Topco Associates LLC | f1e940ef-3cf0-4a5c-8158-156d0e5a680d | 2024-06-13 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Trifecta Pharmaceuticals USA LLC | 026bf664-d598-73de-e063-6394a90a9206 | 2024-06-12 | Warnings | M013 |
| Regular Strength Pain Relief | ACETAMINOPHEN | NuCare Pharmaceuticals,Inc. | 7c73fc75-af9b-177c-e053-2a91aa0ada56 | 2024-06-12 | Warnings | M013 |
| Low Dose Aspirin | ASPIRIN | Topco Associates | 4a6a1dbb-c813-42fd-9bb8-497aec339466 | 2024-06-11 | Warnings | M013 |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN, CAFFEINE | The Kroger Co. | fa234639-caf8-4c52-9ffe-f1c0c057ee5b | 2024-06-10 | Warnings | M013 |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN, CAFFEINE | The Kroger Co. | bc18590d-6481-4efe-8a3b-974f7543b754 | 2024-06-10 | Warnings | M013 |
| ASPIRIN | ASPIRIN | H-E-B | 085b35db-62e4-38db-e063-6394a90a9763 | 2024-06-07 | Warnings | M013 |
| pain and fever | ACETAMINOPHEN | Meijer Distribution Inc | cbfa2a25-f1e7-491e-9b67-ff2f4ba0b6cf | 2024-06-07 | Warnings | M013 |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN, CAFFEINE | The Kroger Co. | 5691ac45-5732-412e-abb8-2bfaac59160e | 2024-06-07 | Warnings | M013 |
| Cafiaspirina Rapid Headache Relief | ASPIRIN, CAFFEINE | Belmora LLC | d890acec-6528-4fb7-8d59-6c572a3f0786 | 2024-06-07 | Warnings | M013 |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN, CAFFEINE | TARGET Corporation | 611bc1ce-460a-44a3-8e2d-b28a399d9a44 | 2024-06-06 | Warnings | M013 |
| Childrens Pain and Fever | ACETAMINOPHEN | Meijer Distribution Inc | 033a6153-2651-4703-8a94-def461838113 | 2024-06-05 | 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 |