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 |
|---|---|---|---|---|---|---|
| MAXIMUM STRENGTH Lidocaine Plus Menthol | LIDOCAINE, MENTHOL | ARMY AND AIR FORCE EXCHANGE SERVICE | 60f72061-d264-424e-b396-5a609076d352 | 2026-08-20 | Warnings | M017 |
| MENTHOL, CAMPHOR | MENTHOL, CAMPHOR | SUNSET PAIN RELIEF | 5980c527-6bcb-a846-e063-6294a90a0788 | 2026-08-20 | Warnings | M017 |
| Pain Relief Patches | CAMPHOR, MENTHOL, METHYL SALICYLATE | Amerisource Bergen | 5fb5e5ce-b268-4444-8b63-ea7ea6abf269 | 2026-08-20 | Warnings | M017 |
| Dr. Scholls Blister Pain Relief Complete Kit | LIDOCAINE | Scholl's Wellness Company LLC | 58c2b35c-e1ed-7ea8-e063-6294a90a1494 | 2026-08-19 | Warnings | M017 |
| Dr. Scholls Blister Pain Relief Complete Kit | LIDOCAINE | Scholl's Wellness Company LLC | 585e740b-e4fa-d2aa-e063-6294a90a0982 | 2026-08-19 | Warnings | M017 |
| Eagle Brand Muscular Balm | MENTHOL, METHYL SALICYLATE | PT. EAGLE INDO PHARMA | 0822bcde-a8ad-be95-e063-6294a90ad208 | 2026-08-19 | Warnings | M017 |
| ANTI ITCH | HYDROCORTISONE | HyVee Inc | 1ab6bbb8-2b91-4c53-9168-b1e85ac296e9 | 2026-08-19 | Warnings | M017 |
| hydrocortisone 1 | HYDROCORTISONE | Kroger Company | f05edff2-2dc5-427c-b52c-518e0aaef4e0 | 2026-08-19 | Warnings | M017 |
| MedPride | HYDROCORTISONE | Shield Line LLC | 2f15d3b3-d1e6-4742-9eac-f956c0ffbba4 | 2026-08-18 | Warnings | M017 |
| Pain Relieving Cream Analgesic | MENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATE | Garcoa, Inc. | 2f736307-5cd4-4a76-9044-4aeecba096cc | 2026-08-18 | Warnings | M017 |
| Lidocaine Pain Relief Roll on | PAIN RELIEF ROLL ON | NeilMed Pharmaceuticals Inc | 58ff9d2d-99e6-8f98-e063-6394a90a8de7 | 2026-08-17 | Warnings | M017 |
| Hydrocortisone with Aloe | HYDROCORTISONE CREAM 1/2% | Sun Pharmaceutical Industries, Inc. | 59337940-c9be-58af-e063-6394a90abe13 | 2026-08-16 | Warnings | M017 |
| SIERQ Numbing | MENTHOL | Putian Licheng District Zhijiancheng Trading Co., Ltd. | 5936c070-d8e4-56e8-e063-6294a90a5600 | 2026-08-16 | Warnings | M017 |
| Jakwork Numbing Cream | NUMBING CREAM | Guangzhou Jingliang Cosmetics Co., Ltd. | 5911d9b0-1acb-3546-e063-6294a90adb3a | 2026-08-15 | Warnings | M017 |
| Re-Lieved Lidocaine Patch | LIDOCAINE PATCH 4% | Transfer Technology | 59072f05-eefa-d823-e063-6394a90a0e1a | 2026-08-14 | Warnings | M017 |
| JJ Care First Aid Burn | BENZALKONIUM CHLORIDE, LIDOCAINE HCI | Nantong Health & Beyond Hygienic Products Inc. | c41621fb-c549-4394-a4cb-cb81ef8c98df | 2026-08-13 | Warnings | M017 |
| JJ Care | HYDROCORTISONE | Nantong Health & Beyond Hygienic Products Inc. | c88fa151-f8a8-4de2-98c9-71319bf53e36 | 2026-08-13 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE | Safetec of America, Inc. | da2b3b2c-11e0-401b-bbd2-d019271d1b3d | 2026-08-13 | Warnings | M017 |
| CVS Pain Relief Roll-On Lidocaine with Lavender | LIDOCAINE HYDROCHLORIDE | CVS Pharmacy | 4aa53176-2103-b47b-e063-6394a90ac735 | 2026-08-12 | Warnings | M017 |
| JUST CBD SOOTHING | MENTHOL, CAMPHOR | Just Brands LLC | 5384e80f-c242-76a1-e063-6294a90aba0b | 2026-08-12 | 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 |