Tetracaine
- Product NDC
- 71888-103
- 11-digit product format
- 718880103
- Labeler code
- 71888
- Product ID
- 71888-103_47faba68-aab7-7eb8-e063-6294a90a3931
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Tetracaine
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Bellus Medical, LLC
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2017-06-01
- Substance
- TETRACAINE HYDROCHLORIDE
- Active strength
- 20 mg/1000mL
- Pharmacologic classes
- Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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 |
|---|---|---|---|---|---|
| 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 | 71888-103-02 | 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 package | package | 71888-103-02 | 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 package | package | 71888-103-02 | 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 | 71888-103-02 | 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 | 71888-103-02 | 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 | 71888-103-02 | 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
- Tetracaine
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TETRACAINE HYDROCHLORIDE | 20 mg/1000mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5NF5D4OPCI | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 60cabb5f-606b-7a74-e053-2a91aa0ac024 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a26f29b9-6919-4f09-a354-491df8d2b97d | Product name | 1 | 20251021 |
| 777d68c6-a5ab-e06c-d314-677b0b9af0c8 | Product name | 2 | 20240508 |
| 122d1fa8-7b9e-49b4-89ce-b062ffd1d947 | Product name | 1 | 20181030 |
| a993dfc5-f219-4460-bde6-30dd724d9ef0 | Product name | 1 | 20160818 |
| 4d7ae718-ed00-bae8-2abe-9eaec1eef7ff | Product name | 1 | 20140508 |
| 9137811f-f279-8640-5aeb-99fa2145d64d | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| Effective | Related label |
|---|---|
| 2023-10-27 | 2% Tetracaine Gel |
| 2023-10-27 | 2% Tetracaine Gel |
| 2020-01-31 | 2% Tetracaine Gel |
| 2020-01-31 | 2% Tetracaine Gel |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71888-103-01 | Tetracaine | 4 mL in 1 PACKET | GEL | 4 | 4 | |
| 71888-103-02 | Tetracaine | 12 in 1 BOX | GEL | 12 | 4 |
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 |
|---|---|---|---|---|---|---|
| MYCO Clinic Pain Relief | MENTHOL | Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions | 604a30c9-2306-47a1-bd31-94b63639dd90 | 2024-11-20 | Warnings | M017 |
| MYCO Clinic Pain Relief | CAMPHOR, MENTHOL | Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions | 0b489420-3b5c-43c5-aab4-0e3720acf9ce | 2024-11-20 | Warnings | M017 |
| MYCO Clinic Pain Relief | CAMPHOR, MENTHOL | Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions | dd906129-a787-4352-856d-d7a915031a6e | 2024-11-20 | Warnings | M017 |
| Walgreens Arthritis Pain Relief Cream | HISTAMINE DIHYDROCHLORIDE | Walgreens Company | 80d3031a-7fa9-4f5b-b85e-c7c6ef314801 | 2024-11-20 | Warnings | M017 |
| Anti-Itch Medicated Maximum Strength | BENZOCAINE AND RESORCINOL | Walgreens Company | 7fd86dcb-edef-4d0d-b389-7ecea595fe67 | 2024-11-20 | Warnings | M017 |
| Walgreens Pain Relief | BENZOCAINE | Walgreens Company | 7cee7234-32cd-4bf3-8a6c-0882585eec7f | 2024-11-20 | Warnings | M017 |
| Walgreens Advanced Scar Gel | ADVANCED SCAR GEL | Walgreens Company | 2c040475-a124-485c-933e-66b452f5ab46 | 2024-11-20 | Warnings | M017 |
| LidoPro Pain Relief | CAPSAICIN AND LIDOCAINE | Clinic Pharma | 274611ea-7fc2-ba3f-e063-6294a90aa50f | 2024-11-19 | Warnings | M017 |
| First Aid Only Sting Relief Pad | BENZOCAINE | Acme United Corporation | 5087cbbd-1bbe-62ed-e054-00144ff8d46c | 2024-11-19 | Warnings | M017 |
| Sting Relief Pad | BENZOCAINE, ISOPROPYL ALCOHOL | Acme United Corporation | 6bb9a782-2394-4c8c-e053-2991aa0a08d4 | 2024-11-19 | Warnings | M017 |
| First Aid Only Sting Relief | BENZOCAINE | Acme United Corporation | 697127d1-c02e-16d2-e053-2a91aa0a39fd | 2024-11-19 | Warnings | M017 |
| First Aid Only Hydrocortisone 1% Anti-Itch | HYDROCORTISONE | Acme United Corporation | e5597b11-b08e-99e1-e053-2a95a90a15a5 | 2024-11-19 | Warnings | M017 |
| Equate Cold Therapy Pain Relieving Roll-on Analgesic | MENTHOL, UNSPECIFIED FORM | Wal-Mart Stores, Inc. | 4115f0ac-e12a-4e59-94f5-a47dcc7f8766 | 2024-11-18 | Warnings | M017 |
| Equate Cold Therapy Pain Relieving Analgesic | MENTHOL, UNSPECIFIED FORM | Wal-Mart Stores, Inc. | ac6c2112-8692-4628-97d8-3a5a9f509766 | 2024-11-18 | Warnings | M017 |
| Equate Odor-Free Therapy Arthritis Analgesic | TROLAMINE SALICYLATE | Wal-Mart Stores, Inc. | 1d73e7b6-c7f9-4680-b3e3-a954b91e1863 | 2024-11-18 | Warnings | M017 |
| First Aid Only Burn | LIDOCAINE HYDROCHLORIDE | Acme United Corporation | 9af39fcd-0a57-26d0-e053-2a95a90a99a0 | 2024-11-17 | Warnings | M017 |
| First Aid Only First Aid/Burn | LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE | Acme United Corporation | caa67a05-bdbd-c380-e053-2995a90a0bf1 | 2024-11-17 | Warnings | M017 |
| Meijer Pain Lidocaine Plus Relieving Analgesic | BENZYL ALCOHOL AND LIDOCAINE HYDROCHLORIDE | Meijer Distribution, Inc | b7385140-3f63-4cbc-b557-de1d29d1ea36 | 2024-11-15 | Warnings | M017 |
| Signature Care Hydrocortisone | HYDROCORTISONE | Safeway | c6b9c4e1-bab8-490d-8c00-c43377ad0857 | 2024-11-15 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE | Walgreen Company | 1a9b8b4c-3e15-49e6-af91-76ed0dc0829e | 2024-11-15 | Warnings | M017 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 71888-103-01 | 71888010301 | 4 mL in 1 PACKET | 4 ml | Historical | |||
| 71888-103-02 | 71888010302 | 12 PACKET in 1 BOX (71888-103-02) / 4 mL in 1 PACKET (71888-103-01) | 12 packet | 2017-06-01 | No | No | Current |