NDC 54575-123

COCKLEBUR POLLEN

Xanthium Strumarium Pollen

COCKLEBUR POLLEN is a Percutaneous; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Allergy Laboratories, Inc.. The primary component is Xanthium Strumarium Pollen.

Product ID	54575-123_dbe7bebd-e445-4e59-8302-e706b795fbde
NDC	54575-123
Product Type	Human Prescription Drug
Proprietary Name	COCKLEBUR POLLEN
Generic Name	Xanthium Strumarium Pollen
Dosage Form	Injection, Solution
Route of Administration	PERCUTANEOUS; SUBCUTANEOUS
Marketing Start Date	1967-12-07
Marketing Category	BLA / BLA
Application Number	BLA101376
Labeler Name	Allergy Laboratories, Inc.
Substance Name	XANTHIUM STRUMARIUM POLLEN
Active Ingredient Strength	1 g/20mL
Pharm Classes	Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]
NDC Exclude Flag	E
Listing Certified Through	2018-12-31

Packaging

NDC 54575-123-02

2 mL in 1 VIAL, MULTI-DOSE (54575-123-02)

Marketing Start Date	1967-12-07
NDC Exclude Flag	N
Sample Package?	N

NDC SPL Data Element Entries

NDC 54575-123-10 [54575012310]

COCKLEBUR POLLEN INJECTION, SOLUTION

Marketing Category	BLA
Application Number	BLA101376
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	1967-12-07
Inactivation Date	2020-01-31

NDC 54575-123-02 [54575012302]

COCKLEBUR POLLEN INJECTION, SOLUTION

Marketing Category	BLA
Application Number	BLA101376
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	1967-12-07
Inactivation Date	2020-01-31

NDC 54575-123-50 [54575012350]

COCKLEBUR POLLEN INJECTION, SOLUTION

Marketing Category	BLA
Application Number	BLA101376
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	1967-12-07
Inactivation Date	2020-01-31

NDC 54575-123-30 [54575012330]

COCKLEBUR POLLEN INJECTION, SOLUTION

Marketing Category	BLA
Application Number	BLA101376
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	1967-12-07
Inactivation Date	2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
XANTHIUM STRUMARIUM POLLEN	1 g/20mL

OpenFDA Data

SPL SET ID:	c1114779-3e11-47ab-8889-f534406f4041
Manufacturer	Allergy Laboratories, Inc.
UNII	BUC5I9595W 1GH3WV23KH 23H70FYJ5U U2AI3H2J5Y 83X1I1RR5F 3K873H631W 5EUI19VT92 6JR6JTN25S 6M98DC08TZ TPL549N9R8 6U600U1326 D7401PWY6E KPO1Z9N98A 7J12CD6O9L 4K7Z7K7SWG 8DS6G120HJ GW0W1Y9I97 3RT3536DHY 68R9X9Y96X 44IDY6DTKX A17SE577FM LJT6I6Z8FD T3PW93IB4Q 380W4HYR6N 0E5AT8T16U G0O5980Z7W 577VA5B4HP HJ4L70T1ZP M9WGG9Z9GK JFH385Y744 098LKX5NCN 17Q05812N1 34X886W1H4 DI0ZRJ0MXN KSY1AWN59I 0N8672707O P6K070AR8V JY1BE33I3Y 7XW7TB10X9 0R4AQI398X YI19RB8YFD 8QF5D5H6UH 87U156LEN7 Z4Y9ZSV4KK Z4KHF2C175 5AN5LR8L3F V1V998DC17 RX18M46K8L X88DF51T48 199I7J3JIV 1FCM16V0FV F1KAH8374D 6HD2W46UEG 8J18RFO4A8 02WM57RXZJ CW657OBU4N EYO007VX98 WIB701MW2H O0HJ02QBWN N4F4RQ7BY7 3538FNV8AY N52MIQ81ZW M98C8416QO O138UB266J 3E0I92Z2GR 0X3XUJ41IX 28D6K7E9IP 5EVU04N5QU W7NU4B5CIY 57KIJ4772H 54C8E6W6JY 2ZN8DWC0YF 2RQ1L9N089 476DVV63WP Z4MD1809H1 7TLR512M4A B55BD1QM4Q Z91WAU43WC 43R41XZ627 928OC2TJDA G684LX721Q X2W7CLE97T N9D69B2Q7Y U6Z259H815 1X92VM01YP KBA5Y6X57N 36R82U4DL6 92N6W6KO2G 95447163DG TGO054E31O TX1ER5UV3T SDS87L369F ON2T85TA2O 492225Q21H I9D9Z5GCW5 4J4DOU3HEK 0G82TT8ZFY 4F35XG0149 LC8MEV9S89 6M2JIH93ZN 786YV7B602 644CZ16IR5 5PO6NN3RRJ L7HT8F1ZOD J7I2T6IV1N 978D8U419H V95R5KMY2B 0MGE63QPFJ 15VX0351MT VU8C8SB23P 4IPS17B70T 5O7CR4P444 T8678F0P0Q Y3FRX92Z0E G515RAI9FY K20Y81ACO3 5Q246DS5BS 81GS97HVFO S8A4X05W7J 6WO75C6WVB 5BGG872373 59070I8M63 758Z9H9WV9 2VWV12V9WR TOQ97Z8644 030R993R8E 4D7G21HDBC D1A2NG69CK 3EM4VW6TQN 2MH135KC6G 6EIJ3D04MR G9O67I0A8Q 1V3SHR7QB7 4PIB2155QP JQ5HI5004M 112YH1ZMX2 24RS0A988O 60RO23IR87 DHI513VXU7 2LN3M29LNI TBW53313S7 51I6N3XIML 52B29REC7H XQ14H1462M W34X0P8636 9L67M8B78R 0WLY635722 V38QUQ7861 917J3173FT 7U437HHU5C 4J2TY8Y81V 3F36V0451W 8JAG41IE4M KHX46H31F8 FEE198DK4Q Q74T35078H 6532U64A3X 58RXI817UT 74PD8J616H 62TY3X4N9Z 91M9RWP3TD 3I9T68187H 8003NOJ82F HR6H5057CO 4110YT348C 26U0BU8G83 5C5403N26O 8E9NT44R8I Q4T1SJ3046 065C5D077J 2A64U81OQ3 2ZAU32517N YY7C30VXJT 7Q7T9Z7QUW 5S29HWU6QB 3Z252A2K9G H3O7QI5HY7 5THQ6K6J4O GG8WX068MX 89Y9MUH0K5 232DMH0XVF 700NK45C76 49W168AES4 XC209ITL3J 390AN9GB09 BBO1IJ3ZIW 17RH99LQ7G DO87T1U2CI G280W4MW6E GM3H4U6QS8 0MVO31Q3QS 9LYI4RTZ52 5PWM7YLI7R 57BTU4547U W4X7H8GYFM 2WZG2G15WX B423VGH5S9 R9N3379M4Z 231473QB6R 49VI1ZSO06 O82C39RR8C G82398SD3I 0X8Q245Y7B R9JBC6687X KM66971LVF 2FV55IRB5B R3NBG8914U CFE1S8DYWD 2XO08315X1 KO7V58BY40 58FMD0Q0EV O12H03B41R 18JOK51CZH PV7823W303 Y05PC4JZRH C5529G5JPQ GQM6LVU5V8 ZEI09763J3 4ZWY20GTGO Z6J799EAJK DNB59M1NVU Z0F2YK1B7H ANT994T71D 5928LJ1441 BKZ683617P UU78E56M7L 3H5U5CX7KO 138LUT2DWV 15XI414745 4AJZ4765R9 0V3J4YEX2W L56Z1JK48B 3Y1PE1GCIG 269CJD5GZ9 ER172J09FM W5U19AK212 7Y1255HVXR M30XO5X4XD UBW6O1H50I IIC6H3WF6J 291P45F896 C91ZMT66YA 41Y752Y34M B7B86Y84R8 VBT3DRA2R9 70LDW53ROO 89BAT511BD 88VZV9HGT4 9935G0V38C 93963RFO1P UOI4FT57BZ QE1QX6B99R GHC6OHK0W0 8A6OMU3I8L A7IKY24TR7 3LN5B70U4W 09N62XQ70Y QBN8K7055X E03U1K03LK PYO4JR720Y 84ZOM591BB 6AU0ZD8T1O 3OKE88I3QG PY0JA16R2G D9108TZ9KG 766QT72BK6 N0Y68724R3 BN2DNW66IQ F14P91GB5F CGF76TP7X6 4J2I0SN84Y 2A88ZO081O 9IOA40ANG6 KU94FIY6JB V825XJG64G 4O1FFR8ARN YI3WT83KTW 5016WB8B8A X92O101CS2 2QOF601J1M 5964J742O8 8KDG09A4GO 8CZS546954 544F8MEY0Y WQ3S5294XY SVW19ET93C V003SHB7VK 605T96G8Y5 VK8C112WTS 83B65P4796 255H8VT4RK 05S7L91ZTR 1BV28146ZR YB1308W43O PM6E3FG1QK KU1V1898XX H20KU95UBG 54UN9R2798 6LK42KUV6W 2U0KZP0FDW 294L626TT0 EM5RP35463 9961HBA483 73B14PX5FW
RxNorm Concept Unique ID - RxCUI	1098197 852327 852323 1094119 852656 901340 900050 852554 895585 1011036 899596 852082 852243 314941 852240 966649 1011020 899352 901377 899354 900116 894940 899469 899358 851735 1014761 852817 968004 889590 1010968 852010 978960 1011972 1014388 852018 1012051 966928 852155 1012055 851893 852139 905501 852135 1006321 1094156 852131 1000013 1098458 1014738 1098501 901379 966705 891724 899672 1115265 892341 905073 899676 901372 1094325 968133 1098622 899475 883409 1299985 1098133 899749 905331 852001 905261 978958 892854 899427 889573 1006300 852535 1094485 904479 1094477 852346 852181 2103256 852342 1098208 852220 1094196 852224 852630 1010942 1010858 897319 899534 896140 1098265 852499 966654 1098121 904965 995561 892623 895573 905279 968470 902747 852032 1011046 852216 852741 852212 852745 852057 851877 852749 900111 852584 967973 852351 900707 899451 1014343 852625 852453 899757 899459 900064 967532 905482 968544 1006513 901316 967777 901310 901014 899919 905363 892619 899664 967038 852023 901256 901018 851917 852200 852049 891661 1014748 852512 1012146 899397 852041 899393 899423 899412 852596 852366 852196 1098396 852612 901358 899745 889650 966998 1006503 904868 894786 901306 1011976 899626 1098260 852117 901025 905099 852297 896224 968416 851905 1011063 891671 852604 892668 891679 904651 899385 852077 899431 1098186 852275 899632 900994 1014410 852151 891644 1098356 896216 968404 1114996 1098441 852228 1014194 899737 901332 1098277 852683 899733 898010 898012 852161 897394 852165 967051 1010854 995746 1010856 852672 904649 851933 852676 1006349 1094492 851937 904642 901320 899389 1011630 995604 852263 897335 1098169 898407 899401 852572 901206 901202 899880 1006509 899882 899886 852422 1099102 851941 867300 1098192 851988 852177 1012035 968429 1010904 899381 905333 895577 852662 851743 891698 851929 852666 852494 891690 966958 904834 891614 1098255 899655 1098250 1013964 852707 852090 852608 899417 1012047 1098235 899898 899493 899366 967977 968474 892487 1098203 901194 895922 1192820 901294 852385 899741 905327 1094377 1010974
Pharm Class PE	Cell-mediated Immunity [PE] Increased IgG Production [PE] Increased Histamine Release [PE]
PHarm Class EPC	Non-Standardized Insect Allergenic Extract [EPC]
NUI Code	N0000185001 N0000175629 N0000185365 N0000171131 N0000184306 N0000007860

Pharmacological Class

Non-Standardized Pollen Allergenic Extract [EPC]
Increased Histamine Release [PE]
Cell-mediated Immunity [PE]
Increased IgG Production [PE]
Pollen [CS]
Allergens [CS]

NDC Crossover Matching brand name "COCKLEBUR POLLEN" or generic name "Xanthium Strumarium Pollen"

NDC	Brand Name	Generic Name
49643-420	Cocklebur Pollen	Xanthium commune
54575-123	COCKLEBUR POLLEN	xanthium strumarium pollen
0268-0053	CENTER-AL - XANTHIUM STRUMARIUM POLLEN	XANTHIUM STRUMARIUM POLLEN
0268-0054	CENTER-AL - XANTHIUM STRUMARIUM POLLEN	XANTHIUM STRUMARIUM POLLEN

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.