DIPHEN
benzocaine, benzalkonium chloride, lidocaine hydrochloride, hydrocortisone, bacitracin zinc, neomycin sulfate, polymyxin b sulfate, calcium carbonate, ibuprofen, loratadine, acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, diphenhydramine hydrochloride, potassium chloride, magnesium oxide, meclizine hydrochloride, and bismuth subsalicylate kit |
| Product Information |
| Product Type | HUMAN OTC DRUG | Item Code (Source) | NDC: 82652-021 |
|
| Packaging |
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date |
| 1 | NDC: 82652-021-01 | 1 in 1 CARTON | 05/10/2022 | |
|
| Quantity of Parts |
| Part # | Package Quantity | Total Product Quantity |
| Part 1 | 4 PACKET | 3 g |
| Part 2 | 2 PACKET | 1.8 g |
| Part 3 | 4 PACKET | 3.6 g |
| Part 4 | 8 PACKET | 4 g |
| Part 5 | 2 PACKET | 4 |
| Part 6 | 4 PACKET | 8 |
| Part 7 | 4 PACKET | 4 |
| Part 8 | 4 PACKET | 8 |
| Part 9 | 4 PACKET | 4 |
| Part 10 | 2 PACKET | 4 |
| Part 11 | 3 PACKET | 6 |
| Part 12 | 4 PACKET | 8 |
| Part 13 | 3 PACKET | 6 |
|
| Part 1 of 13 |
PAIN RELIEF
benzocaine liquid |
|
| Product Information |
| Item Code (Source) | NDC: 82652-033(NDC:61010-8100) |
| Route of Administration | TOPICAL |
|
| Active Ingredient/Active Moiety |
| Ingredient Name | Basis of Strength | Strength |
| benzocaine (UNII: U3RSY48JW5) (benzocaine - UNII:U3RSY48JW5) | benzocaine | 200 mg in 1 g |
|
|
|
|
| Packaging |
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date |
| 1 | NDC: 82652-033-01 | 0.75 g in 1 PACKET; Type 0: Not a Combination Product | | |
|
|
| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph not final | part356 | 05/01/2010 | |
|
| Part 2 of 13 |
BURN
benzalkonium chloride and lidocaine hydrochloride cream |
|
| Product Information |
| Item Code (Source) | NDC: 82652-029(NDC:47682-940) |
| Route of Administration | TOPICAL |
|
| Active Ingredient/Active Moiety |
| Ingredient Name | Basis of Strength | Strength |
| Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) | Benzalkonium Chloride | 1.3 mg in 1 g |
| Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987) | Lidocaine Hydrochloride Anhydrous | 5 mg in 1 g |
|
|
|
|
| Packaging |
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date |
| 1 | NDC: 82652-029-01 | 0.9 g in 1 PACKET; Type 0: Not a Combination Product | | |
|
|
| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC MONOGRAPH NOT FINAL | part348 | 08/29/2017 | |
|
| Part 3 of 13 |
HYDROCORTISONE
hydrocortisone cream |
|
| Product Information |
| Item Code (Source) | NDC: 82652-027(NDC:47682-923) |
| Route of Administration | TOPICAL |
|
| Active Ingredient/Active Moiety |
| Ingredient Name | Basis of Strength | Strength |
| HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (Hydrocortisone - UNII:WI4X0X7BPJ) | HYDROCORTISONE ACETATE | 10 mg in 1 g |
|
|
|
|
| Packaging |
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date |
| 1 | NDC: 82652-027-01 | 0.9 g in 1 PACKET; Type 0: Not a Combination Product | | |
|
|
| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC MONOGRAPH NOT FINAL | part348 | 06/01/2021 | |
|
| Part 4 of 13 |
TRIPLE ANTIBIOTIC
bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointment |
|
| Product Information |
| Item Code (Source) | NDC: 82652-028(NDC:47682-932) |
| Route of Administration | TOPICAL |
|
| Active Ingredient/Active Moiety |
| Ingredient Name | Basis of Strength | Strength |
| Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I) | Bacitracin | 400 [USP'U] in 1 g |
| Neomycin Sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297) | Neomycin | 3.5 mg in 1 g |
| Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) | Polymyxin B | 5000 [USP'U] in 1 g |
|
|
|
|
| Packaging |
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date |
| 1 | NDC: 82652-028-01 | 0.5 g in 1 PACKET; Type 0: Not a Combination Product | | |
|
|
| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC MONOGRAPH FINAL | part333B | 06/04/2018 | |
|
| Part 5 of 13 |
ALCALAK
calcium carbonate tablet, chewable |
|
| Product Information |
| Item Code (Source) | NDC: 82652-023(NDC:47682-201) |
| Route of Administration | ORAL |
|
| Active Ingredient/Active Moiety |
| Ingredient Name | Basis of Strength | Strength |
| Calcium Carbonate (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) | Calcium Carbonate | 420 mg |
|
|
|
| Product Characteristics |
| Color | WHITE | Score | no score |
| Shape | ROUND | Size | 11mm |
| Flavor | | Imprint Code |
AZ;036
|
| Contains | |
|
| Packaging |
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date |
| 1 | NDC: 82652-023-01 | 2 in 1 PACKET; Type 0: Not a Combination Product | | |
|
|
| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC MONOGRAPH FINAL | part331 | 06/15/2014 | |
|
| Part 6 of 13 |
I-PRIN
ibuprofen tablet, film coated |
|
| Product Information |
| Item Code (Source) | NDC: 82652-024(NDC:47682-683) |
| Route of Administration | ORAL |
|
| Active Ingredient/Active Moiety |
| Ingredient Name | Basis of Strength | Strength |
| Ibuprofen (UNII: WK2XYI10QM) (Ibuprofen - UNII:WK2XYI10QM) | Ibuprofen | 200 mg |
|
|
|
| Product Characteristics |
| Color | BROWN | Score | no score |
| Shape | ROUND | Size | 10mm |
| Flavor | | Imprint Code |
44;291
|
| Contains | |
|
| Packaging |
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date |
| 1 | NDC: 82652-024-01 | 2 in 1 PACKET; Type 0: Not a Combination Product | | |
|
|
| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA075010 | 02/01/2021 | |
|
| Part 7 of 13 |
LORADAMED
loratadine tablet, film coated |
|
| Product Information |
| Item Code (Source) | NDC: 82652-022(NDC:47682-203) |
| Route of Administration | ORAL |
|
| Active Ingredient/Active Moiety |
| Ingredient Name | Basis of Strength | Strength |
| Loratadine (UNII: 7AJO3BO7QN) (Loratadine - UNII:7AJO3BO7QN) | Loratadine | 10 mg |
|
| Inactive Ingredients |
| Ingredient Name | Strength |
| Starch, Corn (UNII: O8232NY3SJ) | |
| Lactose Monohydrate (UNII: EWQ57Q8I5X) | |
| Magnesium Stearate (UNII: 70097M6I30) | |
|
| Product Characteristics |
| Color | WHITE | Score | no score |
| Shape | ROUND | Size | 6mm |
| Flavor | | Imprint Code |
RX;526
|
| Contains | |
|
| Packaging |
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date |
| 1 | NDC: 82652-022-01 | 1 in 1 PACKET; Type 0: Not a Combination Product | | |
|
|
| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA076134 | 12/30/2008 | |
|
| Part 8 of 13 |
COLD RELIEF
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet |
|
| Product Information |
| Item Code (Source) | NDC: 82652-032(NDC:47682-725) |
| Route of Administration | ORAL |
|
| Active Ingredient/Active Moiety |
| Ingredient Name | Basis of Strength | Strength |
| Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) | Acetaminophen | 325 mg |
| Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) | Dextromethorphan Hydrobromide | 15 mg |
| Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) | Guaifenesin | 200 mg |
| Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) | Phenylephrine Hydrochloride | 5 mg |
|
|
|
| Product Characteristics |
| Color | WHITE | Score | no score |
| Shape | ROUND | Size | 12mm |
| Flavor | | Imprint Code |
FR;12
|
| Contains | |
|
| Packaging |
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date |
| 1 | NDC: 82652-032-01 | 2 in 1 PACKET; Type 0: Not a Combination Product | | |
|
|
| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC MONOGRAPH FINAL | part341 | 02/01/2021 | |
|
| Part 9 of 13 |
DIPHEN
diphenhydramine hydrochloride tablet, film coated |
|
| Product Information |
| Item Code (Source) | NDC: 82652-031(NDC:47682-166) |
| Route of Administration | ORAL |
|
| Active Ingredient/Active Moiety |
| Ingredient Name | Basis of Strength | Strength |
| Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) | Diphenhydramine Hydrochloride | 25 mg |
|
|
|
| Product Characteristics |
| Color | PINK | Score | no score |
| Shape | CAPSULE | Size | 11mm |
| Flavor | | Imprint Code |
048;D
|
| Contains | |
|
| Packaging |
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date |
| 1 | NDC: 82652-031-01 | 1 in 1 PACKET; Type 0: Not a Combination Product | | |
|
|
| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC MONOGRAPH FINAL | part341 | 02/01/2021 | |
|
| Part 10 of 13 |
MEDI-LYTE
calcium carbonate, potassium chloride, and magnesium oxide tablet |
|
| Product Information |
| Route of Administration | ORAL |
|
| Active Ingredient/Active Moiety |
| Ingredient Name | Basis of Strength | Strength |
| Calcium Carbonate (UNII: H0G9379FGK) (Calcium Cation - UNII:2M83C4R6ZB, Carbonate Ion - UNII:7UJQ5OPE7D) | Calcium Carbonate | 27 mg |
| Potassium Chloride (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698) | Potassium Chloride | 80 mg |
| Magnesium Oxide (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) | Magnesium Oxide | 20 mg |
|
|
|
| Product Characteristics |
| Color | WHITE | Score | no score |
| Shape | ROUND | Size | 9mm |
| Flavor | | Imprint Code | |
| Contains | |
|
| Packaging |
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date |
| 1 | | 2 in 1 PACKET; Type 0: Not a Combination Product | | |
|
|
| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| DIETARY SUPPLEMENT | | 05/10/2022 | |
|
| Part 11 of 13 |
MEDI-MECLIZINE
meclizine hydrochloride tablet |
|
| Product Information |
| Item Code (Source) | NDC: 82652-030(NDC:47682-481) |
| Route of Administration | ORAL |
|
| Active Ingredient/Active Moiety |
| Ingredient Name | Basis of Strength | Strength |
| Meclizine Hydrochloride (UNII: HDP7W44CIO) (Meclizine - UNII:3L5TQ84570) | Meclizine Hydrochloride | 25 mg |
|
|
|
| Product Characteristics |
| Color | YELLOW | Score | no score |
| Shape | ROUND | Size | 9mm |
| Flavor | | Imprint Code |
44;403
|
| Contains | |
|
| Packaging |
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date |
| 1 | NDC: 82652-030-01 | 2 in 1 PACKET; Type 0: Not a Combination Product | | |
|
|
| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC MONOGRAPH FINAL | part336 | 12/14/2020 | |
|
| Part 12 of 13 |
EXTRA STRENGTH APAP
acetaminophen tablet, film coated |
|
| Product Information |
| Item Code (Source) | NDC: 82652-025(NDC:47682-043) |
| Route of Administration | ORAL |
|
| Active Ingredient/Active Moiety |
| Ingredient Name | Basis of Strength | Strength |
| Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) | Acetaminophen | 500 mg |
|
|
|
| Product Characteristics |
| Color | WHITE | Score | no score |
| Shape | ROUND | Size | 12mm |
| Flavor | | Imprint Code |
FR;33
|
| Contains | |
|
| Packaging |
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date |
| 1 | NDC: 82652-025-01 | 2 in 1 PACKET; Type 0: Not a Combination Product | | |
|
|
| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC MONOGRAPH NOT FINAL | part343 | 02/01/2021 | |
|
| Part 13 of 13 |
DIOTAME
bismuth subsalicylate tablet, chewable |
|
| Product Information |
| Item Code (Source) | NDC: 82652-026(NDC:47682-210) |
| Route of Administration | ORAL |
|
| Active Ingredient/Active Moiety |
| Ingredient Name | Basis of Strength | Strength |
| Bismuth Subsalicylate (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE) | Bismuth Subsalicylate | 262 mg |
|
|
|
| Product Characteristics |
| Color | PINK | Score | no score |
| Shape | ROUND | Size | 16mm |
| Flavor | PEPPERMINT | Imprint Code |
RH;046
|
| Contains | |
|
| Packaging |
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date |
| 1 | NDC: 82652-026-01 | 2 in 1 PACKET; Type 0: Not a Combination Product | | |
|
|
| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC MONOGRAPH FINAL | part335 | 04/01/2014 | |
|
|
| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA076134 | 05/10/2022 | |
|